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Dental Low Speed Turbine Handpeice
EUDAMEDClass IIa (EU MDR)
Ref SH11W1Model M1-4/M2-4/M3-4/L/L1-4/L3-4/LN
Identity
- Trade Name
- Dental Low Speed Turbine Handpeice EUDAMED
- Device Name
- Dental Low Speed Handpiece EUDAMED
- Model / Reference
- M1-4/M2-4/M3-4/L/L1-4/L3-4/LN EUDAMEDSH11W1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971119541705 EUDAMED
- Basic UDI-DI
- 697111954LSHRA 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 Low Speed Turbine Handpeice by Guangdong JINME Medical Technology 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 | 697111954LSHRA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangdong JINME Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000033806
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED fb613176-e063-4c6d-8394-41e933cd88af 61 fields · synced Jun 18, 2026