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Septaline Endodontie Paper Points, Color-End-Paper, ISO-Taper, Vario-Taper
EUDAMEDClass IIa (EU MDR)
Ref PL-SEP-33E.1435Ref PL-SEP-33E.1425Ref PL-SEP-33E.14ASPRef PL-SEP-33E.1620Ref PL-SEP-33E.1615Ref PL-SEP-33E.1625Ref PL-SEP-33E.1630Ref PL-SEP-33E.1020
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.1435 EUDAMEDPL-SEP-33E.1425 EUDAMEDPL-SEP-33E.14ASP EUDAMEDPL-SEP-33E.1620 EUDAMEDPL-SEP-33E.1615 EUDAMEDPL-SEP-33E.1625 EUDAMEDPL-SEP-33E.1630 EUDAMEDPL-SEP-33E.1020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069210738 EUDAMED08800069210714 EUDAMED08800069210769 EUDAMED08800069210776 EUDAMED08800069211278 EUDAMED08800069210783 EUDAMED08800069210790 EUDAMED08800069210639 EUDAMED
- Basic UDI-DI
- 880926429PP38 EUDAMED
- Direct Marketing DI
- 08800069210738 EUDAMED08800069210714 EUDAMED08800069210769 EUDAMED08800069210776 EUDAMED08800069211278 EUDAMED08800069210783 EUDAMED08800069210790 EUDAMED08800069210639 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 (8)
- EUDAMED 82f311fe-2363-46f7-bcac-9a8dbf230794 61 fields · synced Jul 29, 2026
- EUDAMED b5ca1bca-4c15-48c2-8f2f-83e98865a2cd 61 fields · synced May 16, 2026
- EUDAMED 19d2a080-60de-4e68-8b0e-7ce964a884ab 61 fields · synced May 17, 2026
- EUDAMED 49bf73a6-41ca-4af5-ab1d-e4715df9ed6c 61 fields · synced May 17, 2026
- EUDAMED 9f44494c-afc3-4089-ab3d-be2f2a783844 61 fields · synced May 17, 2026
- EUDAMED 8a2647cc-1b44-489d-b02b-c9af639c6d24 61 fields · synced May 17, 2026
- EUDAMED a646d254-9558-4828-aece-309d47ac9271 61 fields · synced May 18, 2026
- EUDAMED 6657ed3a-f3bb-49b1-a1c1-cbd514d9b395 61 fields · synced May 18, 2026