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Bilateral extremity set sterile
EUDAMEDClass I (EU MDR)
Ref TRO070-03Model Orthopedic Surgical Pack
Identity
- Trade Name
- Bilateral extremity set sterile EUDAMEDBilateral extremity set EUDAMED
- Device Name
- Orthopedic Surgical Pack EUDAMEDBilateral extremity set EUDAMED
- Model / Reference
- Orthopedic Surgical Pack EUDAMEDTRO070-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288667302 EUDAMED
- Basic UDI-DI
- 69562886JA0003K7 EUDAMEDB-06956288667302 EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Bilateral extremity set sterile 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 cff74e6f-5984-4697-b50c-5e6f103dc3d2 61 fields · synced Oct 6, 2026
- EUDAMED 80cb19d2-9646-4d18-a78c-19023ab7f349 61 fields · synced May 19, 2026