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Disposable Surgical Kit for Implant
EUDAMEDClass I (EU MDR)
Ref 045002AModel Interventional Surgical Pack
Identity
- Trade Name
- Disposable Surgical Kit for Implant EUDAMED
- Device Name
- Disposable Surgical Kit for Implant EUDAMEDInterventional Surgical Pack EUDAMED
- Model / Reference
- Interventional Surgical Pack EUDAMED045002A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288673013 EUDAMED
- Basic UDI-DI
- B-06956288673013 EUDAMED69562886LA0001KV 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
Disposable Surgical Kit for Implant 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-06956288673013 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06956288673013 | 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 460a802a-fc62-4d20-b30d-ba74e7c9b0a2 61 fields · synced Jul 25, 2026
- EUDAMED 6c66d07b-11de-4f55-b9f0-68d72c5ed043 61 fields · synced May 19, 2026