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Straight Handpiece
EUDAMEDClass IIa (EU MDR)
Ref GS SH2 / 801025680Model GS SeriesRef GS SH3 / 801003480Ref GS SH3L / 801003380
Identity
- Trade Name
- Straight Handpiece EUDAMED
- Device Name
- Dental handpiece EUDAMED
- Model / Reference
- GS Series EUDAMEDGS SH2 / 801025680 EUDAMEDGS SH3 / 801003480 EUDAMEDGS SH3L / 801003380 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977190340633 EUDAMED06977190340657 EUDAMED06977190340664 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
Straight 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 (3)
- EUDAMED 65a1e1f0-a89b-4dc4-bd85-7eb9e3bd28ab 61 fields · synced Jul 29, 2026
- EUDAMED 2b725b7e-036f-4bac-acf4-b9c859810402 61 fields · synced May 17, 2026
- EUDAMED b2ac9b6d-534c-42fd-b441-bae1cbdba47c 61 fields · synced May 19, 2026