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Medical devices MDR - in vitro testing and Consultancy services

Medical devices MDR - in vitro testing and Consultancy services
Product Description

We are GLP and ISO13485 certified company for testing Medical devices through ISO 10993 standards, specifically in vitro testing. We provide safety tests and pre-clinical tests for medical devices products. We also support companies under the MDR process. Visit us in our booth and find out more about our MD services catalogue

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Labfit & Pharmapoli

  • PT
  • 2020
    On CPHI since
  • 2
    Certificates
  • 25 - 49
    Employees
Company types
Consultancy
Contract Service
Primary activities
Contract Manufacturer
Laboratory Services
Medical Devices
Other
Regulatory Affairs
View company profile
Categories
more categories Show less

Labfit & Pharmapoli

  • PT
  • 2020
    On CPHI since
  • 2
    Certificates
  • 25 - 49
    Employees
Company types
Consultancy
Contract Service
Primary activities
Contract Manufacturer
Laboratory Services
Medical Devices
Other
Regulatory Affairs
View company profile

More Products from Labfit & Pharmapoli (9)

  • Bioequivalence tests for topical drugs

    Product Bioequivalence tests for topical drugs

    We are a GLP lab specialist in vitro permeation testing, including the bioequivalence tests under the EMA draft guideline. We support pharmaceutical companies through bioequivalence studies. Visit our booth and find out more about our R&D dedicated to this topic.
  • Cosmetics Private Label

    Product Cosmetics Private Label

    We produce cosmetics in private label and contract manufacturing. We have a strong R&D knowledge supporting the formulas that we develop. You can find hygiene and care products, for body, face, hair and intimate skin in our portfolio. We are specialists in women health products.
  • Eficaccy tests in vitro

    Product Eficaccy tests in vitro

    We are a GLP lab providing a broad range of testing services in vitro including effciacy tests for chemicals, cosmetics, drugs, medical devices and other products. Our services are also based in a strong R&D knowledge and we are able to addapt tests to client needs. Visit our booth and find out more about ...
  • Safety and Toxicity in vitro

    Product Safety and Toxicity in vitro

    We are a GLP lab providing safety assessment and toxicological tests in vitro for cosmetics, pharmaceutical, medical devices and chemical products. The tests included covers a wide range of targets including reprodutive toxicity tests for intimate lubricants. We are a EU-NETVAL member working with the Euro...
  • Chemical Characterization

    Product Chemical Characterization

    - Chemical characterization of raw materials and formulations;- Physical-Chemical Methods;
    - Analytical methods.
  • Development of Formulation

    Product Development of Formulation

    Formulation Development- Cosmetic products
    - Medical devices (skin and mucous membranes)
    - Oral supplements
    - Veterinary products
    - Biocidal products
    - Topical medicines

    Stability tests - evaluation of the stability of cosmetic products, medical devices, food supplements and bioci...
  • Efficacy Testing / Bioactivity

    Product Efficacy Testing / Bioactivity

    - Chemical and antiseptic disinfectants;- Textiles; 
    - Plastics; 
    - Bioactivity; 
    - Performance tests for Ecolabel registration; 
    - Bio equivalence tests.
  • Microbiological Quality

    Product Microbiological Quality

    Microbiological Quality and Bioactivity Characterization of Raw Materials and Formulations
    Labfit possesses a microbe library of the ATCC© collection of microorganism strains and isolates of clinical specimens with different susceptibility antibiotic profiles, allowing its use to ascertain the bioactivi...
  • Safety and Toxicity

    Product Safety and Toxicity

    - In vitro testing for skin corrosion (OCDE TG341);- In vitro testing for skin irritation (OCDE TG439 and ISO 10993-23:2021);
    - In vitro testing for eye irritation – HET CAM (ICCVAM)In vitro testing for vaginal irritation (SOP Mattec Epivaginal);
    - In vitro testing for Permeation studies of compounds...

Labfit & Pharmapoli resources (3)

Frequently Viewed Together

  • INJECTABLES

    Product INJECTABLES

    Requiring injectables.EU-GMP is a must.
    EU dossier is a must.
    Licensing and supply model or distributorship.
  • Smart hearing health

    Product Smart hearing health

    TympaHealth, one of our start-up clients, launched the world’s first all-in-one hearing health assessment system, a portable smartphone-enabled otoscope with accompanying smartphone app. Since then, the novel device has been awarded Gold in the internationally recognised UX Design Awards for its innov...
  • BtHCROSS - Dermal filler (cross-linked HA 1,5%/1,75%/2%)

    Product BtHCROSS - Dermal filler (cross-linked HA 1,5%/1,75%/2%)

    BtHCROSS is a biocompatible cross-linked hyaluronic acid hydrogel intended as a dermatological treatment for aesthetic purposes. It is administered by intradermal injection and designed to restore and correct facial volumes and fill wrinkles and folds.
    Depending on the depth of the wrinkles an...
  • BF RYNO - medical device

    Product BF RYNO - medical device

    Medical device adjuvant in restoring the physiological conditions of the nasal mucosa. Useful in pathological conditions of the non-injured nasal mucosa, even in chronic conditions, as an adjuvant in the trophic processes of mucosal repair, to improve breathing and thus promote the recovery of smell pe...
  • Zuma eyebright PURE - preservatives free eye drops with eyebright extract

    Product Zuma eyebright PURE - preservatives free eye drops with eyebright extract

    What are ZUMA świetlik Pure eye drops?

    ZUMA świetlik Pure are soothing eye drops containing the eyebright extract.

     
    What are ZUMA świetlik Pure eye drops used for?

    ZUMA świetlik Pure drops relieve symptoms related to irritation, r...
  • Medical devices for gynecological application

    Product Medical devices for gynecological application

    INGE produces medical devices for vaginal liquid products, creams and suppositories. 50 ml to 180 ml bottles for vaginal shower made of a soft, easily compressible material, also Green. Bottles are available in various shapes - cylindrical or elliptical - customizable with front and back engraving and one-...
  • Apipro oral spray for mouth

    Product Apipro oral spray for mouth

    Apipro® oral mouth spray, by creating a protectivefilm, soothes irritated and inflamed throatand reduces irritation of the oral cavity. These aresymptoms that often accompany certain urbanliving conditions, particularly air-conditionedrooms, and almost always cold from differentorigins (flu, viral infectio...
  • Paediatric Glycerine Suppositories 1.0 g

    Product Paediatric Glycerine Suppositories 1.0 g

    Dr. Müller Pharma provides wide range of products which includes Paediatric Glycerine Suppositories 1.0 g.

    Glycerine in the suppository supports bowel evacuation and stool softening and moistening. It increases the stool volume in the lower part of the large intestine and makes defecation ea...
  • OTIBLOCK spray

    Product OTIBLOCK spray

    Ear solution to remove impacted earwax and prevent relapses while preserving the outer ear physiology. 
  • Biguanelle ® Vaginal Suppositories

    Product Biguanelle ® Vaginal Suppositories

    Medical device for recurrent and/orpersistent vaginal infections • Pharmaceutical form: Vaginal suppositories

    • Clinical trials: One clinical trial demonstrates its efficacy and safety in preventing bacterial vaginosis after surgical treatment for cervical intra-epithel...
  • Dry Powder Inhalers (DPI)

    Product Dry Powder Inhalers (DPI)

    Our dry powder inhalers are derived from the commercially-validated AirFluSal® Gyrohaler® platform, but with a range of user interfaces and payload volumes, giving you confidence of performance and a proven regulatory track record.

    With options for proprietary unit- and multi-unit dose platforms...
  • medEctoin Inhalation Solution

    Product medEctoin Inhalation Solution

    Medical device for supportive treatment to reduce inflammations of the airways. • Supportive treatment and symptom alleviation of diseases of the airways, such as allergic or non-allergic asthma, bronchitis or Chronic Obstructive Pulmonary Disease (COPD)  • Protects and moisturizes the mucosa of t...
  • Springs and Stamped & Bent Parts for Pen Injectors

    Product Springs and Stamped & Bent Parts for Pen Injectors

    Tailor-made solutions in springs, stamping & bending and assemblies for enhanced pen injector performance and patient safety. Pen injectors require patients to manually attach a pen needle, unlike autoinjectors that come with a needle attached. This handheld device enables patients to administer m...
  • Stoppers & Caps

    Product Stoppers & Caps

    Features of our Closures;  • Have passed the leakproofness test and are reliable,  • Can be supplied with an aluminum seal installed,  • Can be produced in different colors,  • Our child-proof caps provide the ideal balance between innovative design, ease of use and reliability, ...
  • Moulds For Drug Delivery Devices

    Product Moulds For Drug Delivery Devices

    IGS GeboJagema offers moulds for drug delivery devices. Features: it is available from metered dose inhalers and insulin pens to dose counters. Contact us for more information.
  • Nasal Spray with Trehalose

    Product Nasal Spray with Trehalose

    Decongestion & protection in case of allergic and non-allergic rhinitis and rhinosinusitis • Decongests the nasal mucosa on a natural way • Promotes the drainage of secretions and flushes out excess mucous, along with allergens, dirt, viruses, and bacteria • Opens the paranasal sinuses and reduces he...
  • Plastic injection molds

    Product Plastic injection molds

    Mold design and manufacturing for Medical and Diagnostic in Vitro plastic devices.
  • Cleanroom plastics injection moulding by GEMÜ

    Product Cleanroom plastics injection moulding by GEMÜ

    GEMÜ manufactures an extensive range of plastic injection-molded components, designed to meet the highest cleanroom standards for medical, pharmaceutical, and diagnostic applications. Our state-of-the-art facilities include partially and fully automated injection molding machines, operating in ISO Class 7 ...
  • EDEDAY – EDENIGHT: HYPERTONIC 0.4% HYALURONIC ACID (OPHTHALMOLOGY - CORN...

    Product EDEDAY – EDENIGHT: HYPERTONIC 0.4% HYALURONIC ACID (OPHTHALMOLOGY - CORN...

    Ededay and Edenight are hypertonic products containing sodium hyaluronate 0.4% and hypertonic agents, indicated for the temporary relief of the symptoms of corneal edema. Ededay eye drops also contains sorbitol (13,5%) and can be used during the day.          Ed...
  • Higienica Mousse Hygienica® Foam Mousse for removing lice and nits

    Product Higienica Mousse Hygienica® Foam Mousse for removing lice and nits

    Effectively destroys lice and nits. Gentle on the scalp, with a pleasant aroma. Quick and easy application. Suitable for children over 6 months. Active ingredient: 5% OCTANE-1,2-DIOL.
  • Paraffin Gauze Dressing B.P. 93

    Product Paraffin Gauze Dressing B.P. 93

    Leno weave cotton gauze impregnated with an ointment of  softparaffin, Gamma Sterile.
  • RSV Hypertonic Saline 3%

    Product RSV Hypertonic Saline 3%

    Naveh Pharma Ltd. offers a wide range of advanced ent line products which includes rsv hypertonic saline 3%. Features: acute bronchiolitis, a viral disease usually common in infants and occurs mainly in winter. Treatment of the disease is primarily supportive and based on maintaining hydration and oxygen s...
  • PRIVATE LABEL PRO

    Product PRIVATE LABEL PRO

    PRIVATE LABEL PRO - Our product - Your brand on PROfessional level

    Gofarm offers private label formulas in many forms: liquids, sprays, gels, lozenges, powders and in various forms of packaging. 
    Why PRIVATE LABEL PRO? Because we offer professional products with the highest quality ...
  • Customized High Speed Indexed Assembly Machines

    Product Customized High Speed Indexed Assembly Machines

    Our custom-designed indexed assembly machines are tailored to specific product requirements and assembly processes. These versatile machines can be dedicated to a single product or accommodate multiple variants through modular stations, interchangeable tooling, flexible feeding systems, and robot integrati...
  • Giaval®

    Product Giaval®

    Featured by one of the highest concentrations of Sodium Hyaluronate available in the market, Giaval® is designed to restore and promote the re-ephitalization of the vaginal mucosa. Besides, Giaval® helps with the normal healing processes.

    Format: 2,7 gr vaginal ovuleIndication of use: ...
  • Parenteral nutrition bags

    Product Parenteral nutrition bags

    The EVA TPN bags are empty containers for use in compounding and storage of sterile medical solutions such as parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The empty bags are filled by connecting them to containers - generally glas...
  • SAFETY DEVICES FOR PRE-FILLED SYRINGES

    Product SAFETY DEVICES FOR PRE-FILLED SYRINGES

    Reiner Medical offers three models of advanced syringes with different features to meet a variety of clinical and safety needs. Each of these models is designed with safety and efficiency in medical environments in mind. The following comparison chart details the specific features of our models, providing ...
  • Nasal Spray

    Product Nasal Spray

    Nasal lavage with saline solution is a hygiene remedy and an effective and preventative co-adjuvant treatment for a number of pathologies such as otitis, rhinitis and sinusitis which start with inflammation of the nasal mucus membranes.
  • Allpresan® diabetic INTENSIVE + REPAIR

    Product Allpresan® diabetic INTENSIVE + REPAIR

    Allpresan® diabetic INTENSIVE + REPAIR for very dry to cracked skin
    USP´s: 
    • Medical skin care with 8 % Urea and biomimetic lipids  • Foam cream provides the skin with lipids and hydration, and repairs the skin barrier within 4 weeks  • Provides the skin on...
  • CATIDRAL®

    Product CATIDRAL®

    Gastroenterology: Description of the device and instructions for use CATIDRAL is a single use device in sachets of powder for extemporaneous oral suspension. Each sachet has to be used one only time after its opening. The content of the sachet should be dissolved in 50 – 100 ml of water. To obtain a homo...
  • RINOSOL 2ACT - Nasal Spray

    Product RINOSOL 2ACT - Nasal Spray

    Rinosol 2ACT acts thanks toa natural active complex oftannins, resins, polysaccharides eflavonoids that interact with thenasal mucosa carrying out adouble action:

    - it frees your nose. It has an action mucus thinner, what about itpromotes elimination.

    - barrier effect against virusesand b...
  • Hemorrhoid - Arnica - Burn Creams Medical dev. Health & Care

    Product Hemorrhoid - Arnica - Burn Creams Medical dev. Health & Care

    NEW Dermatological medical device creams indicated for the treatment of HEMORRHOIDS relieves irritation, swelling, itching and painfARNICA for muscle pains, oedema, bruises and stings
    BURN treats effectively exfoliation, swelling and itching due to burns as well as irritations.
         
  • Dermal Filler | BIO-Rejuvenation | Modified Hyaluronic Acid

    Product Dermal Filler | BIO-Rejuvenation | Modified Hyaluronic Acid

    SEMICAL® Dermal Filler; Supporting the extracellular matrix, increasing intra-cutaneous volume, is also an injection method used in the treatment of wrinkles caused by cicatrix or skin aging. USAGE AREAS SEMICAL® Dermal Filler for face applies to the following regions: • Nasolabial lines
     ...
  • Femaginal Plus Vaginal Ovules

    Product Femaginal Plus Vaginal Ovules

    FEMAGINAL PLUS ovules is a medical device Class IIa based on an improved formula of Boric acid, Hyaluronic acid, Polycarbophyl, Lactic acid, Tocopheryl acetate, Vitamin A, 18-Betaglycyrrhetinic acid and Tea tree oil, indicated in the treatment of vaginal dryness, irritations, burning and infections.
  • Micro infusion pumps

    Product Micro infusion pumps

    Sensile Medical is a pioneer in liquid drug delivery pump devices with a typical total volume of 3 – 20 ml. The subcutaneous medication at home combined with digital solutions is attractive for all stakeholders of the health care System.
  • AI500

    Product AI500

    The AI500 is a pain reliever aid gel. It is formulated to soothe local pain and pain caused by joint movement, help to support the muscle tissue
  • Floo-Off (Upper Respiratory Tract Infections)

    Product Floo-Off (Upper Respiratory Tract Infections)

    Floo-off is a Medical Device, class I (MDD) in form of effervescent fumigation tablet for upper respiratory tract infections. It uses advanced IdrOil-Matrix™ technology to incorporate oily lipophilic active principles in tablets.The product is made of ingredients with a large scientific documentation that ...
  • Cicatridina

    Product Cicatridina

    CICATRIDINA is an adjuvant treatment of the reparative processes in atrophic and dystrophic states of
    the vaginal mucosa. It helps wound healing after childbirth, in gynaecological surgery, in the dystrophies resulting from chemotherapy and ionising radiation. Treatment of the vagina...
  • 41.2mm 64mm capsule based RS01-X

    Product 41.2mm 64mm capsule based RS01-X

    RS01X™ upgrades the best in class RS01 inhaler platform with data and connectivity, while maintaining the simplicity, usability and performance of the original. The inhaler connects wirelessly to the Respiro app and platform. The app serves as a companion to the inhaler, reminding patients when to take a d...
  • PRODUKTIL

    Product PRODUKTIL

    PRODUKTIL is the Bio-regenerating of precursors of collagen, thus facilitates fibroblast to quickly produce tropocollagen that polymerizes in extracellular matrix forming collagen real. Restores elasticity and firmness to skin tissue thanks to the very high concentration and synergy of its components. PR...
  • NutriLen Refresh

    Product NutriLen Refresh

    Treatment of eye irritation and dryness. Range of application
    • in case of burning eyes, foreign body sensation, dryness, redness
    • in case of allergic conjunctivitis 


    NutriLen Refresh is an eye spray, a Medical Device, made up of a slightly hyposmolar,sterile solution, with a ph...
  • Early Pregnancy Test

    Product Early Pregnancy Test

    Rapid Self-Test for the early detection of hCG in human urine sample (10 mUI/mL).
    hCG (Human Chorionic Gonadotropin) is a glycoprotein with hormonal activity associated with pregnancy, whose main function is to provide for the maintenance of gestation, favoring an adequate environment for the developm...
  • Gynella® Natal Ferti Gel

    Product Gynella® Natal Ferti Gel

    Vaginal gel for couples who are trying to conceive. The gel:
    -Not only affects the vaginal mucosa and adjusts its pH, but due to the presence of inositol it can also stimulate sperms - Forms optimal environment for sperms. 
    - Increases the pH to values convenient for natural motility o...
  • Ferrite Tag 0503

    Product Ferrite Tag 0503

    0503 (size in 5x3mm) Ferrite Tag features its small and compact size. It can be embedded to an item to instantly empower it with NFC function. Meanwhile, Ferrite Tag has superior heat tolerance to survive extreme use condition.
  • ENNA FERTILITY (BOOSTING) KIT

    Product ENNA FERTILITY (BOOSTING) KIT

    • Product Name

    ENNA Fertility Kit Home treatment for boosting fertility and increasing chances of pregnancy

    • Indication(s)

    Improves fertility and increases chances of pregnancy naturally

    o Women aged 30 to 45.

    o Women under 30 without getting pregnant aft...
  • Dip molding

    Product Dip molding

    Nolato manufacture products in both natural latex and synthetic latex materials using automated production systems in Class 8 cleanroom and hygiene room environments. Our material technicians have developed our own Nolato material formulations and we can develop customer-specific formulations if necessary....
  • MEASURING CUPS AND DOSING SPOONS

    Product MEASURING CUPS AND DOSING SPOONS

    Capsulit S.P.A offers a wide range of medical devices which includes MEASURING CUPS and DOSING SPOONS. Features: It is considered as class I medical devices with dosage functions, they are manufactured and sold with the CE mark. Contact us for more information.
  • PANAVIRAL LINE - No room for viruses and bacteria

    Product PANAVIRAL LINE - No room for viruses and bacteria

    A daily, safe, non-pharmacological strategy to preventnasal infections, leaving no room for viruses and bacteria. Two different presentations: • PANAVIRAL SPRAY, Medical Device class I, Presentation: 20 ml Spray • PANAVIRAL DROPS, Medical Device class I, Presentation: 15 ml Drops
  • Akutol™ Spray

    Product Akutol™ Spray

    AKUTOL™ spray is used for quick treatment of minor abrasions and superficial wounds. Covers the injury with a flexible film that prevents access of foreign substances from the outside environment while allowing the skin to breathe. Waterproof bandage prevents moisture evaporation from the skin.
  • Hostaform® MT® POM

    Product Hostaform® MT® POM

    Celanese provides wide range of products which includes hostaform® mt® pom. It belongs to medical filtration category. Properties: very tough (to -40°c); very hard and rigid; easy colorization; good heat distortion temperature (to 100°c); very good slip/wear properties; excellent chemical resistance to fue...