Identity
- Trade Name
- Air motor EUDAMED
- Device Name
- Dental handpiece EUDAMED
- Model / Reference
- GS Series EUDAMEDGS AM1B2 / 801027380 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977190340497 EUDAMED
- Basic UDI-DI
- 697719034GSTiTK EUDAMED
- EMDN Code
- L15900801 PNEUMATIC SYSTEM TIPS FOR DENTAL USE, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
Air motor by Foshan Koungsun Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697719034GSTiTK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Foshan Koungsun Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000045023
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 768125b5-dfa0-4de1-a8e7-eae493b0ea36 61 fields · synced Jun 19, 2026