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Opero Set Reinforced Universal Set With Gowns
EUDAMEDClass I (EU MDR)
Ref W910000079Model General Surgical Pack
Identity
- Trade Name
- OPERO SET REINFORCED UNIVERSAL SET WITH GOWNS EUDAMEDReinforced universal set with gowns l EUDAMED
- Device Name
- General Surgical Pack EUDAMEDReinforced universal set with gowns l EUDAMED
- Model / Reference
- General Surgical Pack EUDAMEDW910000079 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288660273 EUDAMED
- Basic UDI-DI
- 69562886MA0004LG EUDAMEDB-06956288660273 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 Reinforced Universal 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 | 69562886MA0004LG | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69562886MA0004LG | 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 10139047-d32f-4c1d-a733-36d67727edb3 61 fields · synced Oct 6, 2026
- EUDAMED a3e8922f-7d5c-49ca-a64f-f96c44b2ea3b 61 fields · synced May 19, 2026