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W-OPERO SET Gyneacology/urology set
EUDAMEDClass I (EU MDR)
Ref W915201000Model General Surgical Pack
Identity
- Trade Name
- W-OPERO SET Gyneacology/urology set EUDAMED
- Device Name
- General Surgical Pack EUDAMED
- Model / Reference
- General Surgical Pack EUDAMEDW915201000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288674096 EUDAMED
- Basic UDI-DI
- 69562886MA0002LC EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) 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
W-OPERO SET Gyneacology/urology set by Cobes Industries(Hefei) Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69562886MA0002LC | 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 (1)
- EUDAMED 7185d1a6-f2e6-4d63-9185-aee3f0fcf5b2 61 fields · synced Oct 6, 2026