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High-speed air turbine handpiece
EUDAMEDClass IIa (EU MDR)
Ref GS Ti4SL / 802004881Model GS SeriesRef GS Ti45N / 802007581Ref GS Ti45B2 / 802008581Ref GS Ti4B2 / 802008481Ref GS Ti2N / 802007281Ref GS Ti4S / 802007981Ref GS Ti4M4 / 802003381Ref GS Ti4NL / 802004381Ref GS Ti45K / 802007081Ref GS Ti1S / 802007681Ref GS Ti4KL / 802003881Ref GS Ti4K / 802006981Ref GS Ti1B2 / 802008381Ref GS Ti1M4 / 802003810Ref GS Ti3N / 802007381Ref GS Ti3KL / 802003781Ref GS Ti2NL / 802004181
Identity
- Trade Name
- High-speed air turbine handpiece EUDAMED
- Device Name
- Dental handpiece EUDAMED
- Model / Reference
- GS Series EUDAMEDGS Ti4SL / 802004881 EUDAMEDGS Ti45N / 802007581 EUDAMEDGS Ti45B2 / 802008581 EUDAMEDGS Ti4B2 / 802008481 EUDAMEDGS Ti2N / 802007281 EUDAMEDGS Ti4S / 802007981 EUDAMEDGS Ti4M4 / 802003381 EUDAMEDGS Ti4NL / 802004381 EUDAMEDGS Ti45K / 802007081 EUDAMEDGS Ti1S / 802007681 EUDAMEDGS Ti4KL / 802003881 EUDAMEDGS Ti4K / 802006981 EUDAMEDGS Ti1B2 / 802008381 EUDAMEDGS Ti1M4 / 802003810 EUDAMEDGS Ti3N / 802007381 EUDAMEDGS Ti3KL / 802003781 EUDAMEDGS Ti2NL / 802004181 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977190340435 EUDAMED06977190340244 EUDAMED06977190340091 EUDAMED06977190340084 EUDAMED06977190340213 EUDAMED06977190340282 EUDAMED06977190340138 EUDAMED06977190340381 EUDAMED06977190340190 EUDAMED06977190340251 EUDAMED06977190340336 EUDAMED06977190340183 EUDAMED06977190340053 EUDAMED06977190340107 EUDAMED06977190340220 EUDAMED06977190340329 EUDAMED06977190340367 EUDAMED
- Basic UDI-DI
- 697719034GSTiTK EUDAMED
- Direct Marketing DI
- 06977190340091 EUDAMED06977190340084 EUDAMED06977190340053 EUDAMED
- EMDN Code
- L15900801 PNEUMATIC SYSTEM TIPS FOR DENTAL USE, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMEDIceland 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
High-speed air turbine 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 |
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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 (17)
- EUDAMED 9c7f7b08-2fbb-45b7-8442-951a83f65e30 61 fields · synced Oct 5, 2026
- EUDAMED 1871b3a9-499c-4cc3-8ee0-b1310f9c467f 61 fields · synced May 11, 2026
- EUDAMED e4f3b86c-2da3-4e1a-abe5-926ff3fd20ff 61 fields · synced May 16, 2026
- EUDAMED fb9b7dc0-a241-4e40-8a10-b95d76ca0667 61 fields · synced May 16, 2026
- EUDAMED 19d72a08-6b3d-47f3-afcb-0ea99c058be5 61 fields · synced May 17, 2026
- EUDAMED 631fb789-5d28-4e9e-b8bd-2f06d97c80ed 61 fields · synced May 17, 2026
- EUDAMED 40f75ca5-f6f4-4bce-b360-e528221082f6 61 fields · synced May 17, 2026
- EUDAMED 822c4bc6-e73c-4558-aeab-2b61f11f5fec 61 fields · synced May 17, 2026
- EUDAMED 924c2b05-3910-4bd0-9127-3b36a2e3ecbf 61 fields · synced May 17, 2026
- EUDAMED bf82c108-f83c-4e98-8247-a70d5e9ef64d 61 fields · synced May 17, 2026
- EUDAMED 5cd5f333-2f17-4631-bd25-4d2e026b2f8d 61 fields · synced May 18, 2026
- EUDAMED c1dcc67b-6711-41b9-8e6e-e9a96540e866 61 fields · synced May 18, 2026
- EUDAMED a02bf9dd-3d6a-4b36-8af8-e1ca58a39197 61 fields · synced May 18, 2026
- EUDAMED 0ffa1a63-afdb-4aa2-b337-4fb7c5e0db96 61 fields · synced May 18, 2026
- EUDAMED 61c7752f-e8c1-4a41-be1f-6c753c369c88 61 fields · synced May 18, 2026
- EUDAMED 91e4c61b-2bb5-48b4-800e-c98e963585d5 61 fields · synced May 18, 2026
- EUDAMED 78f64fe6-53fe-495b-85ad-1b87976535c0 61 fields · synced May 19, 2026