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U split drape sterile
EUDAMEDClass I (EU MDR)
Ref CHO16-01Model Surgical drapes
Identity
- Trade Name
- U split drape sterile EUDAMEDU split drape EUDAMED
- Device Name
- Surgical drapes EUDAMEDU split drape EUDAMED
- Model / Reference
- Surgical drapes EUDAMEDCHO16-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288650502 EUDAMED
- Basic UDI-DI
- 69562886BA0002FV EUDAMEDB-06956288650502 EUDAMED
- EMDN Code
- T02010101 INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT 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
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
U split drape sterile 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 | 69562886BA0002FV | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69562886BA0002FV | Class I | Active |
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Manufacturer
- Manufacturer
- Cobes Industries(Hefei) Co., Ltd
- EUDAMED SRN
- CN-MF-000012364
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED a22175b5-9a28-43b3-b1c1-9bce7e500835 61 fields · synced Aug 4, 2026
- EUDAMED a10b0ca3-7ee4-4c1a-9abe-7a43e20968bb 61 fields · synced May 18, 2026