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OPERO DRAPE Surgical drape, sterile
EUDAMEDClass I (EU MDR)
Ref W611158010Model Surgical drapes
Identity
- Trade Name
- OPERO DRAPE Surgical drape, sterile EUDAMEDNonwoven fenestrated drape EUDAMED
- Device Name
- Surgical drapes EUDAMEDNonwoven fenestrated drape EUDAMED
- Model / Reference
- Surgical drapes EUDAMEDW611158010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288645249 EUDAMED
- Basic UDI-DI
- 69562886BA0002FV EUDAMEDB-06956288645249 EUDAMED
- EMDN Code
- T02010101 INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
OPERO DRAPE Surgical 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 f73d669f-75dc-493c-9c67-4118fe5b1d37 61 fields · synced Jun 19, 2026
- EUDAMED 331fe0bc-1c93-4c0a-a10a-3b136fc28689 61 fields · synced May 19, 2026