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Fenestrated drape sterile
EUDAMEDClass I (EU MDR)
Ref CHO13-04Model Type A Surgical DrapeModel Surgical drapes
Identity
- Trade Name
- Fenestrated drape sterile EUDAMEDFenestrated drape EUDAMED
- Device Name
- Surgical drapes EUDAMEDFenestrated drape EUDAMED
- Model / Reference
- Type A Surgical Drape EUDAMEDCHO13-04 EUDAMEDSurgical drapes EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288645607 EUDAMED
- Basic UDI-DI
- 69562886BA0001FT EUDAMEDB-06956288645607 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 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 | 69562886BA0001FT | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69562886BA0001FT | 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 6da0adf3-bdd8-4a96-8849-21eb8cb679d1 61 fields · synced Jul 24, 2026
- EUDAMED b5e6bc15-2158-42df-8bba-54202a0e7062 61 fields · synced May 18, 2026