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Dental treatment unit
EUDAMEDClass IIa (EU MDR)
Ref KLT-6210Model KLT-6210 序列号：S3
Identity
- Trade Name
- Dental treatment unit EUDAMED
- Device Name
- Dental treatment unit EUDAMED
- Model / Reference
- KLT-6210 序列号：S3 EUDAMEDKLT-6210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970940030280 EUDAMED
- Basic UDI-DI
- B-06970940030280 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Category: Dental delivery system
Dental treatment unit by Foshan Roson Medical Instruments Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06970940030280 | 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 62a36759-5a8a-451a-91b7-1dfddb74cf4c 61 fields · synced Jun 18, 2026