← Back to catalogue
Contra-angle handpiece
EUDAMEDClass IIa (EU MDR)
Ref GS X4 / 801026880Model GS SeriesRef GS X1 / 801020480Ref GS X4L / 801024880Ref GS X3 / 801019980Ref GS X2 / 801025580Ref GS X1L / 801020380
Identity
- Trade Name
- Contra-angle handpiece EUDAMED
- Device Name
- Dental handpiece EUDAMED
- Model / Reference
- GS Series EUDAMEDGS X4 / 801026880 EUDAMEDGS X1 / 801020480 EUDAMEDGS X4L / 801024880 EUDAMEDGS X3 / 801019980 EUDAMEDGS X2 / 801025580 EUDAMEDGS X1L / 801020380 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977190340589 EUDAMED06977190340534 EUDAMED06977190340596 EUDAMED06977190340565 EUDAMED06977190340541 EUDAMED06977190340558 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
Contra-angle handpiece 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Foshan Koungsun Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000045023
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (6)
- EUDAMED 59c26859-6ce3-4896-84e9-6ec60f686b79 61 fields · synced Jul 29, 2026
- EUDAMED 96c23a4c-65e5-4f2b-b048-02e2e4cee9a5 61 fields · synced May 16, 2026
- EUDAMED c8b51fb3-811c-40ea-982a-087127817026 61 fields · synced May 17, 2026
- EUDAMED c2e4ab0f-ac9e-4dbc-be0c-f788140108d7 61 fields · synced May 18, 2026
- EUDAMED af6d4bd6-d4f6-410b-80b4-dd0d533285c0 61 fields · synced May 18, 2026
- EUDAMED 83d78613-9f0e-480b-b92c-7f2a2db554f5 61 fields · synced May 18, 2026