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Opero Set Urology Set With Gowns
EUDAMEDClass I (EU MDR)
Ref W910000708Model General Surgical Pack
Identity
- Trade Name
- OPERO SET UROLOGY SET WITH GOWNS EUDAMEDUrology set with gowns EUDAMED
- Device Name
- General Surgical Pack EUDAMEDUrology set with gowns EUDAMED
- Model / Reference
- General Surgical Pack EUDAMEDW910000708 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288673815 EUDAMED
- Basic UDI-DI
- 69562886MA0005LJ EUDAMEDB-06956288673815 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 With Gowns 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 c23a46c6-815a-4afd-8219-98b61d95a970 61 fields · synced Oct 6, 2026
- EUDAMED 2d409fa5-beba-46df-ac20-6cc8e6f45c2d 61 fields · synced May 18, 2026