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OPERO DRAPE Surgical drape, sterile
EUDAMEDClass I (EU MDR)
Ref W611163010Model Type A Surgical DrapeModel Surgical drapes
Identity
- Trade Name
- OPERO DRAPE Surgical drape, sterile EUDAMEDNonwoven Fenestrated drape EUDAMED
- Device Name
- Surgical drapes EUDAMEDNonwoven Fenestrated drape EUDAMED
- Model / Reference
- Type A Surgical Drape EUDAMEDW611163010 EUDAMEDSurgical drapes EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288640367 EUDAMED
- Basic UDI-DI
- 69562886BA0001FT EUDAMEDB-06956288640367 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 | 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 96490560-2751-47f7-89e4-bd3a4d9985f6 61 fields · synced Oct 6, 2026
- EUDAMED 25df5436-e38d-475f-825d-0f3993a8dbc9 61 fields · synced May 19, 2026