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Dental high speed turbine handpiece
EUDAMEDClass IIa (EU MDR)
Ref Lotus 403P-B2Model Lotus401-M4/Lotus401-B2/Lotus401P-M4/Lotus401P-B2/Lotus402-M4/Lotus402-B2/Lotus402P-M4/Lotus402P-B2/Lotus403-M4/Lotus403-B2/Lotus403P-M4/Lotus403P-B2/Lotus401PQ/Lotus401PBQ/Lotus401P45Ref Lotus 403P-B2
Identity
- Trade Name
- Dental high speed turbine handpiece EUDAMED
- Device Name
- Dental high speed turbine handpiece EUDAMED
- Model / Reference
- Lotus401-M4/Lotus401-B2/Lotus401P-M4/Lotus401P-B2/Lotus402-M4/Lotus402-B2/Lotus402P-M4/Lotus402P-B2/Lotus403-M4/Lotus403-B2/Lotus403P-M4/Lotus403P-B2/Lotus401PQ/Lotus401PBQ/Lotus401P45 EUDAMEDLotus 403P-B2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941617210595 EUDAMED
- Basic UDI-DI
- 69416172HSM3Q EUDAMEDB-06941617210595 EUDAMED
- Direct Marketing DI
- 06941617210595 EUDAMED
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria 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
Dental high speed turbine handpiece by Being Foshan Medical Equipment Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69416172HSM3Q | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69416172HSM3Q | Class IIa | Active |
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Manufacturer
- Manufacturer
- Being Foshan Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000028786
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 4d1871a8-db22-49c0-90a2-c8b2533fd6bc 61 fields · synced Jul 20, 2026
- EUDAMED 49ebcd1f-3f53-4ff0-a52f-8f3d46b865cf 61 fields · synced Jun 18, 2026