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OPERO SET Laparoscopy ll set
EUDAMEDClass I (EU MDR)
Ref W916000000Model General Surgical Pack
Identity
- Trade Name
- OPERO SET Laparoscopy ll set EUDAMEDLaparoscopy ll set EUDAMED
- Device Name
- General Surgical Pack EUDAMEDLaparoscopy ll set EUDAMED
- Model / Reference
- General Surgical Pack EUDAMEDW916000000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288669115 EUDAMED
- Basic UDI-DI
- 69562886MA0001LA EUDAMEDB-06956288669115 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 Laparoscopy ll 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 | 69562886MA0001LA | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69562886MA0001LA | 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 5a144c3b-2668-411a-b75a-6a2354d24303 61 fields · synced Oct 6, 2026
- EUDAMED a854021b-ff5d-4007-bf12-561085b2f109 61 fields · synced May 17, 2026