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OPERO SET Abdominal set
EUDAMEDClass I (EU MDR)
Ref W917000000Model General Surgical Pack
Identity
- Trade Name
- OPERO SET Abdominal set EUDAMEDAbdominal set EUDAMED
- Device Name
- General Surgical Pack EUDAMEDAbdominal set EUDAMED
- Model / Reference
- General Surgical Pack EUDAMEDW917000000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288669139 EUDAMED
- Basic UDI-DI
- 69562886MA0003LE EUDAMEDB-06956288669139 EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMEDPoland 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 Abdominal 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 | 69562886MA0003LE | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69562886MA0003LE | 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 e3db8abc-4fec-4eb7-90a7-d023b38da717 61 fields · synced Jul 10, 2026
- EUDAMED 90f73143-7476-4c33-8c2f-4ff373817608 61 fields · synced May 19, 2026