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Gutta Percha Points
EUDAMEDClass IIa (EU MDR)
Ref R25,R40,R50-assorted/60/markedModel Gutta Percha Points
Identity
- Model / Reference
- Gutta Percha Points EUDAMEDR25,R40,R50-assorted/60/marked EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974922407688 EUDAMED
- Basic UDI-DI
- 697492240GP3U EUDAMED
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
Gutta Percha Points by Shanghai Xingyu Medical Equipment 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 | 697492240GP3U | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai Xingyu Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000032268
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (4)
- EUDAMED 5cee21de-5f01-463d-8183-53c8c783d4ae 61 fields · synced Oct 8, 2026
- EUDAMED 5cee21de-5f01-463d-8183-53c8c783d4ae-1 61 fields · synced Jun 9, 2026
- EUDAMED 5cee21de-5f01-463d-8183-53c8c783d4ae-2 61 fields · synced Jun 9, 2026
- EUDAMED 5cee21de-5f01-463d-8183-53c8c783d4ae-3 61 fields · synced Jun 9, 2026