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Septaline Endodontie Paper Points, Color-End-Paper, ISO-Taper, Vario-Taper
EUDAMEDClass IIa (EU MDR)
Ref PL-SEP-33E.10ASP
Identity
- Trade Name
- Septaline Endodontie Paper Points, Color-End-Paper, ISO-Taper, Vario-Taper EUDAMED
- Device Name
- Sterile Absorbent Paper Points EUDAMED
- Model / Reference
- PL-SEP-33E.10ASP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069210684 EUDAMED
- Basic UDI-DI
- 880926429PP38 EUDAMED
- Direct Marketing DI
- 08800069210684 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
Yes
EUDAMED
Implantable
No
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 Paper Points, Color-End-Paper, 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 | 880926429PP38 | 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 322d6052-ed6b-4d5b-ae3d-4a5f842b31c6 61 fields · synced Jun 19, 2026