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Dental Unit
EUDAMEDClass IIa (EU MDR)
Ref 007Model E200A, E200B, E200C, E200D, E200E, E200F, E200G, E200H, E200I, E200J, E200K, E200L, S500A, S500B, S500C, S500D, S500E, S500F
Identity
- Trade Name
- Dental Unit EUDAMED
- Model / Reference
- E200A, E200B, E200C, E200D, E200E, E200F, E200G, E200H, E200I, E200J, E200K, E200L, S500A, S500B, S500C, S500D, S500E, S500F EUDAMED007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974901650074 EUDAMED
- Basic UDI-DI
- 697490165D-UnitRY EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Category: Dental delivery system
Dental Unit by Sichuan Bomesin Dental Equipment Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697490165D-UnitRY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sichuan Bomesin Dental Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000031442
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (1)
- EUDAMED bd362d30-9932-4739-8688-104d2105d732 61 fields · synced Jun 18, 2026