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Surgical drape
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 277502Model Surgical drapesModel Type A Surgical Drape
Identity
- Trade Name
- Surgical drape EUDAMEDSurgical drape sterile EUDAMED
- Device Name
- Surgical drapes EUDAMED
- Model / Reference
- Surgical drapes EUDAMED277502 EUDAMEDType A Surgical Drape EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288640015 EUDAMED
- Basic UDI-DI
- B-06956288640015 EUDAMED69562886BA0001FT EUDAMED
- EMDN Code
- T020199 SURGICAL DRAPES - OTHER 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
Surgical drape by Cobes Industries(Hefei) Co., Ltd — Class I — FDA_510K, MDD, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112378 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06956288640015 | Class I | Active |
| EUDAMED | European Union | CE/MDR | B-06956288640015 | 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 (3)
- EUDAMED 45431e12-f063-4b42-b39e-70c20b820230 61 fields · synced Jul 13, 2026
- EUDAMED 9832f9a5-c88e-40db-b40e-497a83aac4bb 61 fields · synced May 17, 2026
- FDA 510(k) K112378 1 fields · synced May 18, 2026