Identity
- Model / Reference
- Gutta Percha Points EUDAMEDZ35/60pc EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976806527437 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
Z35/60pc 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 (1)
- EUDAMED 36343dac-387f-4a01-a724-76ecd118c5a1 61 fields · synced Jun 19, 2026