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Dental Unit
EUDAMEDClass IIa (EU MDR)
Ref 012Model E200A, E200B, E200C, E200D, E200E, E200F, E200G, E200H, E200I, E200J, E200K, E200L, S500A, S500B, S500C, S500D, S500E, S500FRef 008Ref 014Ref 005Ref 006Ref 015Ref 018Ref 013Ref 009Ref 011Ref 003Ref 004
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 EUDAMED012 EUDAMED008 EUDAMED014 EUDAMED005 EUDAMED006 EUDAMED015 EUDAMED018 EUDAMED013 EUDAMED009 EUDAMED011 EUDAMED003 EUDAMED004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974901650128 EUDAMED06974901650081 EUDAMED06974901650142 EUDAMED06974901650043 EUDAMED06974901650067 EUDAMED06974901650159 EUDAMED06974901650180 EUDAMED06974901650135 EUDAMED06974901650098 EUDAMED06974901650111 EUDAMED06974901650012 EUDAMED06974901650036 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 (12)
- EUDAMED 4e4ae031-bb27-4f1a-a1cc-f43408dcef21 61 fields · synced Oct 6, 2026
- EUDAMED ee9d6cb0-516e-4cb5-b381-7f89e7fe60c5 61 fields · synced May 17, 2026
- EUDAMED e3e5d5b9-00e1-4a8c-a472-4b8ce2105d9f 61 fields · synced May 17, 2026
- EUDAMED 28c8ff9a-3dfd-4469-a122-2bf626c73fc4 61 fields · synced May 17, 2026
- EUDAMED 3df142d7-d451-4b05-82a9-8552905972cf 61 fields · synced May 17, 2026
- EUDAMED 11b03c0a-45fd-4ed2-84da-2b1f48cdd1d2 61 fields · synced May 17, 2026
- EUDAMED 3de5eba1-80b8-47a2-baf5-8a5a0bd18dc7 61 fields · synced May 17, 2026
- EUDAMED 13f4041d-8761-4578-83e3-2e58eb408617 61 fields · synced May 18, 2026
- EUDAMED d7a35e6c-a463-4c6a-b129-2f9b659fa32f 61 fields · synced May 18, 2026
- EUDAMED 58da7521-6170-4fa0-bb0e-d70830207eb7 61 fields · synced May 18, 2026
- EUDAMED 2d0f473f-16c2-4eaa-aff2-cead59eb9b30 61 fields · synced May 18, 2026
- EUDAMED b3a93021-bf01-4073-8e70-fc4351e81e51 61 fields · synced May 19, 2026