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Dental low speed handpiece
EUDAMEDClass IIa (EU MDR)
Ref Rose 201CAI5Model Rose201CA/Rose201CAP/Rose201CAR /Rose201CAR20 /Rose201CAR20B /Rose201CAI/ose201CAI-B/Rose201CAI5/Rose201CAI5-B/Rose201CAI45/Rose201CAI45-B/Rose201SH/Rose201SHR/Rose201SHI/Rose201-M4 /Rose201-B2/Rose202CA/Rose202CAP/Rose202CAP-B/Rose202CAR
Identity
- Trade Name
- Dental low speed handpiece EUDAMEDDental low speed handpiece EUDAMED
- Device Name
- Dental low speed handpiece EUDAMEDDental low speed handpiece EUDAMED
- Model / Reference
- Rose201CA/Rose201CAP/Rose201CAR /Rose201CAR20 /Rose201CAR20B /Rose201CAI/ose201CAI-B/Rose201CAI5/Rose201CAI5-B/Rose201CAI45/Rose201CAI45-B/Rose201SH/Rose201SHR/Rose201SHI/Rose201-M4 /Rose201-B2/Rose202CA/Rose202CAP/Rose202CAP-B/Rose202CAR EUDAMEDRose 201CAI5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941617210038 EUDAMED
- Basic UDI-DI
- 69416172LSM4C EUDAMEDB-06941617210038 EUDAMED
- Direct Marketing DI
- 06941617210038 EUDAMED
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece 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 low speed 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 | 69416172LSM4C | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69416172LSM4C | 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 c613744f-f0e7-437b-a140-8ab9a223f119 61 fields · synced Jul 9, 2026
- EUDAMED 780d2b92-fb9f-4cf6-9f88-7715b6ee3d4b 61 fields · synced Jun 19, 2026