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Opero Set Urology Set
EUDAMEDClass I (EU MDR)
Ref W910000700Model General Surgical Pack
Identity
- Trade Name
- OPERO SET UROLOGY SET EUDAMEDUrology set EUDAMED
- Device Name
- General Surgical Pack EUDAMEDUrology set EUDAMED
- Model / Reference
- General Surgical Pack EUDAMEDW910000700 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288673785 EUDAMED
- Basic UDI-DI
- 69562886MA0005LJ EUDAMEDB-06956288673785 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
Opero Set Urology Set 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 | 69562886MA0005LJ | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69562886MA0005LJ | 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 c54ee635-6b79-4af7-93b3-d3abd2e4a5b8 61 fields · synced Jun 18, 2026
- EUDAMED 33b34b80-1130-4a01-a1f5-97f88474edfb 61 fields · synced May 17, 2026