Identity
- Trade Name
- Surgical drapes EUDAMEDUnder buttock Drape EUDAMED
- Device Name
- Surgical drapes EUDAMEDUnder buttock Drape EUDAMED
- Model / Reference
- Surgical drapes EUDAMEDS57001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288657013 EUDAMED
- Basic UDI-DI
- 69562886BA0004FZ EUDAMEDB-06956288657013 EUDAMED
- EMDN Code
- T020102 SPECIALISTIC SURGERY DRAPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMEDIreland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Surgical drapes by Cobes Industries(Hefei) Co., Ltd — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69562886BA0004FZ | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69562886BA0004FZ | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cobes Industries(Hefei) Co., Ltd
- EUDAMED SRN
- CN-MF-000012364
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 39dbbbbf-57f5-4ade-b92f-d42a696252e3 61 fields · synced Oct 6, 2026
- EUDAMED 06804d0c-4cb7-494d-8fcf-2c5df9bfebfd 61 fields · synced May 18, 2026