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F6 SkyTaper® Guttapercha Points
EUDAMEDClass IIa (EU MDR)
Ref GPF06.000.030Ref GPF06.000.S1Ref GPF06.000.025
Identity
- Trade Name
- F6 SkyTaper® Guttapercha Points EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- GPF06.000.030 EUDAMEDGPF06.000.S1 EUDAMEDGPF06.000.025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069203655 EUDAMED08800069203686 EUDAMED08800069203648 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069203655 EUDAMED08800069203686 EUDAMED08800069203648 EUDAMED
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
F6 SkyTaper® Guttapercha Points 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 (3)
- EUDAMED 2ec92ffd-9e4a-4a2f-858c-17aea597a365 61 fields · synced Aug 1, 2026
- EUDAMED 3fc7ec76-4015-4dd1-858b-fa09127c7ce9 61 fields · synced May 19, 2026
- EUDAMED 829a8bdb-74d4-4507-8756-6bf68f90691e 61 fields · synced May 19, 2026