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Dental high speed turbine handpiece
EUDAMEDClass IIa (EU MDR)
Ref Lotus 402-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 Lotus401-B2Ref Lotus 403-B2Ref Lotus 302PB-M4Ref Lotus 302Ref Lotus 401-M4Ref Lotus 302PQ-M4Ref Lotus 401P-B2Ref Lotus 401Ref Lotus 303PBQ-M4Ref Lotus 303PQRef Lotus 302PBQRef Lotus 401S45Ref Lotus 402P-M4Ref Lotus 401PQRef Lotus401P-M4Ref Lotus 303PQ45Ref Lotus 303Ref Lotus 303PBQ45Ref Lotus 302PQ-B2Ref Lotus 403-M4Ref Lotus 403Ref Lotus 401P45Ref Lotus302P-B2Ref Lotus302P-M4Ref Lotus 303PBQRef Lotus 302PQ-ARef Lotus 303PQ-KRef Lotus302PQ-M4Ref Lotus 303PQ-WRef Lotus 302PQ-SRef Lotus 405PE-M4Ref Lotus 303PBQ-SRef Lotus302PQ- B2Ref Lotus 302PE-M4Ref Lotus 405PE-B2Ref Lotus 401P45-NRef Lotus 302PQ-WRef Lotus302PB-M4Ref Lotus403-B2Ref Lotus402-B2Ref Lotus 402PRef Lotus 401PE-M4Ref Lotus401-M4Ref Lotus 402SRef Lotus 401S45-M4Ref Lotus 302PBQ-ARef Lotus 401PE-B2Ref Lotus 303PBQ-W
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 402-B2 EUDAMEDLotus401-B2 EUDAMEDLotus 403-B2 EUDAMEDLotus 302PB-M4 EUDAMEDLotus 302 EUDAMEDLotus 401-M4 EUDAMEDLotus 302PQ-M4 EUDAMEDLotus 401P-B2 EUDAMEDLotus 401 EUDAMEDLotus 303PBQ-M4 EUDAMEDLotus 303PQ EUDAMEDLotus 302PBQ EUDAMEDLotus 401S45 EUDAMEDLotus 402P-M4 EUDAMEDLotus 401PQ EUDAMEDLotus401P-M4 EUDAMEDLotus 303PQ45 EUDAMEDLotus 303 EUDAMEDLotus 303PBQ45 EUDAMEDLotus 302PQ-B2 EUDAMEDLotus 403-M4 EUDAMEDLotus 403 EUDAMEDLotus 401P45 EUDAMEDLotus302P-B2 EUDAMEDLotus302P-M4 EUDAMEDLotus 303PBQ EUDAMEDLotus 302PQ-A EUDAMEDLotus 303PQ-K EUDAMEDLotus302PQ-M4 EUDAMEDLotus 303PQ-W EUDAMEDLotus 302PQ-S EUDAMEDLotus 405PE-M4 EUDAMEDLotus 303PBQ-S EUDAMEDLotus302PQ- B2 EUDAMEDLotus 302PE-M4 EUDAMEDLotus 405PE-B2 EUDAMEDLotus 401P45-N EUDAMEDLotus 302PQ-W EUDAMEDLotus302PB-M4 EUDAMEDLotus403-B2 EUDAMEDLotus402-B2 EUDAMEDLotus 402P EUDAMEDLotus 401PE-M4 EUDAMEDLotus401-M4 EUDAMEDLotus 402S EUDAMEDLotus 401S45-M4 EUDAMEDLotus 302PBQ-A EUDAMEDLotus 401PE-B2 EUDAMEDLotus 303PBQ-W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941617212117 EUDAMED06941617212087 EUDAMED06941617212155 EUDAMED06941617211875 EUDAMED06941617211882 EUDAMED06941617212070 EUDAMED06941617211851 EUDAMED06941617212100 EUDAMED06941617211745 EUDAMED06941617211790 EUDAMED06941617210885 EUDAMED06941617211837 EUDAMED06941617210571 EUDAMED06941617212131 EUDAMED06941617211776 EUDAMED06941617212094 EUDAMED06941617210847 EUDAMED06941617211769 EUDAMED06941617210762 EUDAMED06941617211868 EUDAMED06941617212148 EUDAMED06941617211806 EUDAMED06941617210496 EUDAMED06941617210618 EUDAMED06941617210670 EUDAMED06941617210793 EUDAMED06941617221133 EUDAMED06941617221188 EUDAMED06941617221249 EUDAMED06941617221096 EUDAMED06941617221409 EUDAMED06941617221232 EUDAMED06941617221362 EUDAMED06941617221416 EUDAMED06941617221324 EUDAMED06941617221119 EUDAMED06941617220990 EUDAMED06941617221386 EUDAMED06941617220983 EUDAMED06941617221355 EUDAMED06941617221140 EUDAMED06941617221393 EUDAMED06941617221256 EUDAMED
- Basic UDI-DI
- 69416172HSM3Q EUDAMEDB-06941617221133 EUDAMEDB-06941617221188 EUDAMEDB-06941617211851 EUDAMEDB-06941617221249 EUDAMEDB-06941617221096 EUDAMEDB-06941617221409 EUDAMEDB-06941617221232 EUDAMEDB-06941617211868 EUDAMEDB-06941617212087 EUDAMEDB-06941617221362 EUDAMEDB-06941617221416 EUDAMEDB-06941617221324 EUDAMEDB-06941617210618 EUDAMEDB-06941617221119 EUDAMEDB-06941617211875 EUDAMEDB-06941617212155 EUDAMEDB-06941617212117 EUDAMEDB-06941617220990 EUDAMEDB-06941617221386 EUDAMEDB-06941617212070 EUDAMEDB-06941617220983 EUDAMEDB-06941617221355 EUDAMEDB-06941617221140 EUDAMEDB-06941617221393 EUDAMEDB-06941617221256 EUDAMED
- Direct Marketing DI
- 06941617212117 EUDAMED06941617212087 EUDAMED06941617212155 EUDAMED06941617211875 EUDAMED06941617211882 EUDAMED06941617212070 EUDAMED06941617211851 EUDAMED06941617212100 EUDAMED06941617211745 EUDAMED06941617211790 EUDAMED06941617210885 EUDAMED06941617211837 EUDAMED06941617210571 EUDAMED06941617212131 EUDAMED06941617211776 EUDAMED06941617212094 EUDAMED06941617210847 EUDAMED06941617211769 EUDAMED06941617210762 EUDAMED06941617211868 EUDAMED06941617212148 EUDAMED06941617211806 EUDAMED06941617210496 EUDAMED06941617210618 EUDAMED06941617210670 EUDAMED06941617210793 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 (51)
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- EUDAMED d834e51a-90db-41d4-8b0a-10e161eab57d 61 fields · synced May 16, 2026
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- EUDAMED 42c99a6c-5ef0-4646-8719-f70914b65a6d 61 fields · synced May 17, 2026
- EUDAMED a9283170-73ca-4309-bbba-6f877ca271eb 61 fields · synced May 17, 2026
- EUDAMED d8b50de7-56e4-47d3-87b8-259e00717032 61 fields · synced May 17, 2026
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- EUDAMED b0368d1c-860f-4573-b295-db063e2ad9a1 61 fields · synced May 18, 2026
- EUDAMED 0ac87ef8-2d4b-4d60-a1cc-c9300da44aad 61 fields · synced May 18, 2026
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- EUDAMED 7212f5d1-8637-45dd-aea5-0aa17717738f 61 fields · synced May 19, 2026
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- EUDAMED 42dc5f3b-7669-4162-a186-0a5cd47b988d 61 fields · synced May 19, 2026
- EUDAMED 9b681a55-8ad8-43d7-8c22-1bce86f27db3 61 fields · synced Jun 18, 2026
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- EUDAMED 32dedbc9-7cce-4b86-abe9-6e80d7015899 61 fields · synced Jul 11, 2026
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- EUDAMED ed1c804c-6ac1-4fdb-b676-0c44198fbd0e 61 fields · synced Jul 15, 2026
- EUDAMED 11dc4d16-aa82-49a4-bd92-3f9741b75241 61 fields · synced Jul 15, 2026
- EUDAMED 1a27ea94-4b2a-43d7-9bfc-c5a38de97d8c 61 fields · synced Jul 15, 2026
- EUDAMED a4704587-967c-4540-806d-b124431d6eea 61 fields · synced Jul 16, 2026
- EUDAMED 394ab3f9-eabd-4b7b-8de8-d1bdbf4533ed 61 fields · synced Jul 16, 2026
- EUDAMED a4c4d84a-709a-4977-94e6-96681db4f966 61 fields · synced Jul 16, 2026