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COMFIT® Premium Gants chirurgicaux stériles poudrés en latex Taille: 8
EUDAMEDClass IIa (EU MDR)
Ref H35114PModel COMFIT® Premium Gants chirurgicaux stériles poudrés en latex Taille: 8
by Adhe-Els SA.
Identity
- Trade Name
- COMFIT® Premium Gants chirurgicaux stériles poudrés en latex Taille: 8 EUDAMED
- Device Name
- COMFIT® Premium Gants chirurgicaux stériles EUDAMED
- Model / Reference
- COMFIT® Premium Gants chirurgicaux stériles poudrés en latex Taille: 8 EUDAMEDH35114P EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-H35114PBJ EUDAMED
- Basic UDI-DI
- B-H35114PBJ EUDAMED
- EMDN Code
- T01010101 POWDERED LATEX SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
COMFIT® Premium Gants chirurgicaux stériles poudrés en latex Taille: 8 by Adhe-Els SA. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-H35114PBJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Adhe-Els SA.
- EUDAMED SRN
- TN-MF-000011757
- Authorised Representative
- ADHE-ELS FRANCE FR-AR-000001654
Sources (1)
- EUDAMED b9fdf21a-eace-4ccf-8089-87325450463e 61 fields · synced Oct 6, 2026