← Back to catalogue
Dental Low Speed Turbine Handpiece
EUDAMEDClass IIa (EU MDR)
Ref AC111Model M1-4/M2-4/M3-4/L/L1-4/L3-4/LN
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 EUDAMEDAC111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971119542214 EUDAMED
- Basic UDI-DI
- 697111954LSHRA EUDAMED
- Direct Marketing DI
- 06971119542214 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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 — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental delivery system.
- Dental Unit — Lifedent (Zhuhai) Co., Ltd. · Class IIa
- V8 TOUCH — VITALI S.R.L. · Class IIa
- Forest — Ls Enterprises, Inc. · Class I
- Forest — Ls Enterprises, Inc. · Class I
- TY-830 — Foshan Toye Dental Equipment Co., Ltd · Class I
- Forest — Ls Enterprises, Inc. · Class I
- A5 SINGLE CART — CEFLA s.c. · Class IIa
- Forest — Ls Enterprises, Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
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 925be141-33b9-407a-bd12-a837bf534e5a 61 fields · synced Jun 19, 2026