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Orthopedics set
EUDAMEDClass I (EU MDR)
Ref TRO070-09Model Orthopedic Surgical Pack
Identity
- Trade Name
- Orthopedics set EUDAMEDOrthopedics set sterile EUDAMED
- Device Name
- Orthopedics set EUDAMEDOrthopedic Surgical Pack EUDAMED
- Model / Reference
- Orthopedic Surgical Pack EUDAMEDTRO070-09 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288667364 EUDAMED
- Basic UDI-DI
- B-06956288667364 EUDAMED69562886JA0003K7 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
Orthopedics set by Cobes Industries(Hefei) Co., Ltd — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06956288667364 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06956288667364 | Class I | Active |
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Manufacturer
- Manufacturer
- Cobes Industries(Hefei) Co., Ltd
- EUDAMED SRN
- CN-MF-000012364
- Authorised Representative
- DISPOMED S.A.S FR-AR-000000891
Sources (2)
- EUDAMED a607fa74-48db-4441-98a8-259bf27e37a0 61 fields · synced Sep 18, 2026
- EUDAMED 0a9ad6af-eedb-46bd-96aa-64e25e2ae5c4 61 fields · synced May 19, 2026