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Disposable Sterile Surgical Kit
EUDAMEDClass I (EU MDR)
Ref 045004AMYModel Stomatology packRef 045004AMP
Identity
- Trade Name
- DISPOSABLE STERILE SURGICAL KIT EUDAMED
- Device Name
- Stomatology pack EUDAMED
- Model / Reference
- Stomatology pack EUDAMED045004AMY EUDAMED045004AMP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288674010 EUDAMED06956288673990 EUDAMED
- Basic UDI-DI
- 69562886HA0001J9 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 — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 49006b0e-882c-439c-99f0-ce1ca13197a9 61 fields · synced Jul 23, 2026
- EUDAMED 8b086410-403a-4295-b2d3-55f4ecfe96f0 61 fields · synced May 17, 2026