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Dental Low Speed Turbine Handpiece
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref SH111Model M1-4/M2-4/M3-4/L/L1-4/L3-4/LNRef AAW41Ref W112Ref W11W3Ref L3-4Ref AC11W1Ref AM41Ref M2-4Ref AS11W1Ref AS11W3Ref M3-4Ref SH112Ref AM42Ref AMW41Ref AAW42Ref AC11W3
Identity
- Trade Name
- Dental Low Speed Turbine Handpiece EUDAMED
- Device Name
- Dental Low Speed Handpiece EUDAMED
- Model / Reference
- M1-4/M2-4/M3-4/L/L1-4/L3-4/LN EUDAMEDSH111 EUDAMEDAAW41 EUDAMEDW112 EUDAMEDW11W3 EUDAMEDL3-4 EUDAMEDAC11W1 EUDAMEDAM41 EUDAMEDM2-4 EUDAMEDAS11W1 EUDAMEDAS11W3 EUDAMEDM3-4 EUDAMEDSH112 EUDAMEDAM42 EUDAMEDAMW41 EUDAMEDAAW42 EUDAMEDAC11W3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971119541712 EUDAMED06971119541828 EUDAMED06971119542177 EUDAMED06971119542139 EUDAMED06971119540814 EUDAMED06971119542191 EUDAMED06971119541750 EUDAMED06971119540784 EUDAMED06971119541675 EUDAMED06971119541651 EUDAMED06971119540791 EUDAMED06971119541729 EUDAMED06971119541774 EUDAMED06971119541736 EUDAMED06971119541842 EUDAMED06971119542115 EUDAMED
- Basic UDI-DI
- 697111954LSHRA EUDAMED
- Direct Marketing DI
- 06971119541828 EUDAMED06971119542177 EUDAMED06971119540814 EUDAMED06971119542191 EUDAMED06971119541750 EUDAMED06971119540784 EUDAMED06971119541675 EUDAMED06971119541651 EUDAMED06971119540791 EUDAMED06971119541729 EUDAMED06971119541774 EUDAMED06971119541842 EUDAMED06971119542115 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMEDZ12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDPoland 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 Handpiece by Guangdong JINME Medical Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170236 | Class IIa | Active |
| 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 (17)
- EUDAMED 766d0331-d02d-405d-a376-f6b58b2da497 61 fields · synced Aug 4, 2026
- EUDAMED 1c162a38-08a8-48a4-875e-0191523a3cbc 61 fields · synced May 16, 2026
- EUDAMED 4b6482a2-2483-4889-b694-e87f2223c897 61 fields · synced May 16, 2026
- EUDAMED ef96b539-6f47-460a-9a99-ceaf6541b904 61 fields · synced May 17, 2026
- EUDAMED 341bfc7e-af23-4ce5-9b31-ec0686111e5d 61 fields · synced May 17, 2026
- EUDAMED 9cf8b2e8-1a43-4c64-95b3-d6680a1a8fc8 61 fields · synced May 17, 2026
- EUDAMED 68efcdb9-465d-498c-b5cd-c27c36a7e5ff 61 fields · synced May 17, 2026
- EUDAMED 37a7bc2d-4942-4083-93fe-e7e57ee777fb 61 fields · synced May 17, 2026
- EUDAMED 05d756d4-1dda-4d39-b741-16cda4e26613 61 fields · synced May 17, 2026
- EUDAMED fcf93e17-794f-4d80-aad2-6171765813a7 61 fields · synced May 17, 2026
- EUDAMED 88c8d370-4186-4768-b228-9d815faabecd 61 fields · synced May 17, 2026
- EUDAMED fdc54753-4e31-42ce-810d-23f30c59af67 61 fields · synced May 18, 2026
- EUDAMED 63165579-cdbb-4903-9702-7c34a2c849fc 61 fields · synced May 18, 2026
- EUDAMED 6e582f19-d0b8-44ed-8af4-08f324042dcf 61 fields · synced May 18, 2026
- EUDAMED 1dd2915a-c114-451d-bf65-439b9983e8bf 61 fields · synced May 18, 2026
- EUDAMED 937150c9-987c-4375-8096-1af785d7c557 61 fields · synced May 19, 2026
- FDA 510(k) K170236 1 fields · synced May 18, 2026