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Septaline Endodontie Gutta Ponts, Color-End-Gutta, ISO-Taper, Vario-Taper
EUDAMEDClass IIa (EU MDR)
Ref PL-SEP-33E.0425
Identity
- Trade Name
- Septaline Endodontie Gutta Ponts, Color-End-Gutta, ISO-Taper, Vario-Taper EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- PL-SEP-33E.0425 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069210479 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069210479 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
Septaline Endodontie Gutta Ponts, Color-End-Gutta, ISO-Taper, Vario-Taper by Sure Dent Corporation — Class IIa — MDR — listed in EUDAMED
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 (1)
- EUDAMED 4f85ffb9-0a75-48df-8e11-2eb345017d37 61 fields · synced Jun 17, 2026