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Fenestrated drape
EUDAMEDClass I (EU MDR)
Ref CHO13-06Model Surgical drapesModel Type A Surgical Drape
Identity
- Trade Name
- Fenestrated drape EUDAMEDFenestrated drape sterile EUDAMED
- Device Name
- Fenestrated drape EUDAMEDSurgical drapes EUDAMED
- Model / Reference
- Surgical drapes EUDAMEDCHO13-06 EUDAMEDType A Surgical Drape EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288645737 EUDAMED
- Basic UDI-DI
- B-06956288645737 EUDAMED69562886BA0001FT 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
Fenestrated 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-06956288645737 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06956288645737 | 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 8de8213a-49dc-47be-a08f-658c996827c5 61 fields · synced Jun 19, 2026
- EUDAMED 7415c0e3-4448-4515-8106-4462cf58b131 61 fields · synced May 17, 2026