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Dental treatment unit
EUDAMEDClass IIa (EU MDR)
Ref KLT-6210Model KLT-6210 序列号：N2+
Identity
- Trade Name
- Dental treatment unit EUDAMED
- Device Name
- Dental treatment unit EUDAMED
- Model / Reference
- KLT-6210 序列号：N2+ EUDAMEDKLT-6210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970940030273 EUDAMED
- Basic UDI-DI
- B-06970940030273 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dental treatment unit by Foshan Roson Medical Instruments Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06970940030273 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Foshan Roson Medical Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000024527
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED b2055234-6c89-4eed-afee-eeb7726a92e1 61 fields · synced Jun 17, 2026