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XP-4D ® Bio GP Cones
EUDAMEDClass IIa (EU MDR)
Ref 08.600.03.025.RERef 08.600.03.S25.RERef 08.600.03.015.RERef 08.600.03.035.RE
Identity
- Trade Name
- XP-4D ® Bio GP Cones EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- 08.600.03.025.RE EUDAMED08.600.03.S25.RE EUDAMED08.600.03.015.RE EUDAMED08.600.03.035.RE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069204911 EUDAMED08800069204942 EUDAMED08800069204904 EUDAMED08800069204928 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069204911 EUDAMED08800069204942 EUDAMED08800069204904 EUDAMED08800069204928 EUDAMED
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
XP-4D ® Bio GP Cones by Sure Dent Corporation — 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 | 880926429GP2D | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sure Dent Corporation
- EUDAMED SRN
- KR-MF-000018662
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED 8a4b2afd-afee-46f9-8454-622d39df6d64 61 fields · synced Jul 23, 2026
- EUDAMED 610ad54a-2558-4cc6-8f13-e6d69f4c41b5 61 fields · synced May 17, 2026
- EUDAMED 04855f05-d1da-4ad6-832a-8eab811b4363 61 fields · synced May 18, 2026
- EUDAMED 3dca270c-46a0-4aed-8146-5c96953ba9af 61 fields · synced May 18, 2026