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Steriblue Gutta Points, Color-End-Gutta, ISO-Taper, Vario-Taper
EUDAMEDClass IIa (EU MDR)
Ref SB-PG4TP020
Identity
- Trade Name
- Steriblue Gutta Points, Color-End-Gutta, ISO-Taper, Vario-Taper EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- SB-PG4TP020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069209930 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069209930 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
Steriblue Gutta Points, Color-End-Gutta, ISO-Taper, Vario-Taper 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 (1)
- EUDAMED cde94269-f18e-4d70-8489-9d1c155c6688 61 fields · synced Jun 19, 2026