Identity
- Trade Name
- U split drape EUDAMEDU split drape sterile EUDAMED
- Device Name
- U split drape EUDAMEDSurgical drapes EUDAMED
- Model / Reference
- Surgical drapes EUDAMEDCHO16-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288650533 EUDAMED
- Basic UDI-DI
- B-06956288650533 EUDAMED69562886BA0002FV 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 by Cobes Industries(Hefei) Co., Ltd — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06956288650533 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06956288650533 | Class I | Active |
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Manufacturer
- Manufacturer
- Cobes Industries(Hefei) Co., Ltd
- EUDAMED SRN
- CN-MF-000012364
- Authorised Representative
- DISPOMED S.A.S FR-AR-000000891
Sources (2)
- EUDAMED de3c46d8-f216-4fc5-8d8d-da8bf303fbd1 61 fields · synced Oct 6, 2026
- EUDAMED cc71356a-9fee-4fa8-9113-965ab92ac020 61 fields · synced May 18, 2026