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Shoe cover
EUDAMEDClass I (EU MDR)
Ref ACC-CCH-002Model Clothing, draping and care sets NEODRAP
by Adhe-Els SA.
Identity
- Trade Name
- Shoe cover EUDAMED
- Device Name
- NEODRAP®Shoe cover EUDAMED
- Model / Reference
- Clothing, draping and care sets NEODRAP EUDAMEDACC-CCH-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ACC-CCH-0026M EUDAMED
- Basic UDI-DI
- B-ACC-CCH-0026M EUDAMED
- EMDN Code
- T020102,T020199 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
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
Shoe cover by Adhe-Els SA. — Class I — 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-ACC-CCH-0026M | Class I | 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 ca2a1b45-2d92-45da-a85b-d47a7bfd071e 61 fields · synced Jun 19, 2026