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COMFIT® Premium Gants chirurgicaux stériles poudrés en latex Taille:7
EUDAMEDClass IIa (EU MDR)
Ref H35112PModel COMFIT® Premium Gants chirurgicaux stériles poudrés en latex Taille:7Ref H35113PModel COMFIT® Premium Gants chirurgicaux stériles poudrés en latex Taille:7,5
by Adhe-Els SA.
Identity
- Trade Name
- COMFIT® Premium Gants chirurgicaux stériles poudrés en latex Taille:7 EUDAMEDCOMFIT® Premium Gants chirurgicaux stériles poudrés en latex Taille:7,5 EUDAMED
- Device Name
- COMFIT® Premium Gants chirurgicaux stériles EUDAMED
- Model / Reference
- COMFIT® Premium Gants chirurgicaux stériles poudrés en latex Taille:7 EUDAMEDH35112P EUDAMEDCOMFIT® Premium Gants chirurgicaux stériles poudrés en latex Taille:7,5 EUDAMEDH35113P EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-H35112PBC EUDAMEDD-H35113PBF EUDAMED
- Basic UDI-DI
- B-H35112PBC EUDAMEDB-H35113PBF 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
No
EUDAMEDEUDAMED
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:7 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-H35112PBC | 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 (2)
- EUDAMED 5db5cbb8-2af2-4297-aebb-6c31e9c543e1 61 fields · synced Oct 6, 2026
- EUDAMED c3449fa0-d0dc-4d2d-8a16-ea2673236eb7 61 fields · synced May 18, 2026