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Opero Set Hand Set
EUDAMEDClass I (EU MDR)
Ref W910700000Model Orthopedic Surgical Pack
Identity
- Trade Name
- OPERO SET HAND SET EUDAMEDHand set EUDAMED
- Device Name
- Orthopedic Surgical Pack EUDAMEDHand set EUDAMED
- Model / Reference
- Orthopedic Surgical Pack EUDAMEDW910700000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288667210 EUDAMED
- Basic UDI-DI
- 69562886JA0003K7 EUDAMEDB-06956288667210 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 Hand 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 | 69562886JA0003K7 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69562886JA0003K7 | 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 19b2c6c8-ff33-479e-a013-b174ed283c6b 61 fields · synced Jun 19, 2026
- EUDAMED 0d5f3898-b780-4974-9476-2dbe9cc13309 61 fields · synced May 18, 2026