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Disposable Sterile Surgical Kit
EUDAMEDClass I (EU MDR)
Ref 045004AMBModel Stomatology pack
Identity
- Trade Name
- DISPOSABLE STERILE SURGICAL KIT EUDAMEDDisposable Surgical Kit EUDAMED
- Device Name
- Stomatology pack EUDAMEDDisposable Surgical Kit EUDAMED
- Model / Reference
- Stomatology pack EUDAMED045004AMB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288673853 EUDAMED
- Basic UDI-DI
- 69562886HA0001J9 EUDAMEDB-06956288673853 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 Sterile Surgical Kit 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 b4869b27-1918-45e3-b3e5-ae87dcd7cedd 61 fields · synced Oct 6, 2026
- EUDAMED 7fdc0ea7-fd72-4ddc-b711-5c4e4c0a535a 61 fields · synced May 19, 2026