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Co-Comfit® /comfit®
EUDAMEDClass IIa (EU MDR)
Ref H35101P/ H35102P/ H35103P/ H35104P/ H35105P/ H35106P/ H35111P/ H35110P/H35112P/ H35113P/ H35114P/ H35115PModel Natural rubber latex sterile surgical gloves
by Adhe-Els SA.
Identity
- Trade Name
- CO-COMFIT® /COMFIT® EUDAMED
- Device Name
- Natural rubber latex powdred sterile surgical gloves EUDAMED
- Model / Reference
- Natural rubber latex sterile surgical gloves EUDAMEDH35101P/ H35102P/ H35103P/ H35104P/ H35105P/ H35106P/ H35111P/ H35110P/H35112P/ H35113P/ H35114P/ H35115P EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-TN-MF-000011757K5 EUDAMED
- Basic UDI-DI
- B-TN-MF-000011757K5 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
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
Co-Comfit® /comfit® 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-TN-MF-000011757K5 | 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 2da4e550-1145-44dc-a3d0-f8144ed5d1eb 61 fields · synced Jul 11, 2026