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Disposable Surgical Kit for Implant
EUDAMEDClass I (EU MDR)
Ref 540NWModel Stomatology pack
Identity
- Trade Name
- Disposable Surgical Kit for Implant EUDAMED
- Device Name
- Stomatology pack EUDAMEDDisposable Surgical Kit for Implant EUDAMED
- Model / Reference
- Stomatology pack EUDAMED540NW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288673228 EUDAMED
- Basic UDI-DI
- 69562886HA0001J9 EUDAMEDB-06956288673228 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 — 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 | 69562886HA0001J9 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69562886HA0001J9 | 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 7affea2f-e969-4085-955c-f870e374a94f 61 fields · synced Jun 19, 2026
- EUDAMED 527a8d8d-a6d3-46f3-bab6-d58daaab2b31 61 fields · synced May 17, 2026