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Opero Set Hand/Foot Set
EUDAMEDClass I (EU MDR)
Ref W910800000Model Orthopedic Surgical Pack
Identity
- Trade Name
- OPERO SET HAND/FOOT SET EUDAMEDHand / foot set EUDAMED
- Device Name
- Orthopedic Surgical Pack EUDAMEDHand / foot set EUDAMED
- Model / Reference
- Orthopedic Surgical Pack EUDAMEDW910800000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288667128 EUDAMED
- Basic UDI-DI
- 69562886JA0003K7 EUDAMEDB-06956288667128 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/Foot 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 6eb09b4a-8719-4b1b-bbeb-79a116d9a18a 61 fields · synced Jun 18, 2026
- EUDAMED 528f02bc-63e6-4f6b-aaf9-c516cbd793ad 61 fields · synced May 19, 2026