← Back to catalogue
Procodile® Guttapercha Points
EUDAMEDClass IIa (EU MDR)
Ref GPPR04.000.045Ref GPPR04.000.050Ref GPPR06.000.020Ref GPPR06.000.S1
Identity
- Trade Name
- Procodile® Guttapercha Points EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- GPPR04.000.045 EUDAMEDGPPR04.000.050 EUDAMEDGPPR06.000.020 EUDAMEDGPPR06.000.S1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069203808 EUDAMED08800069203815 EUDAMED08800069203754 EUDAMED08800069203822 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069203808 EUDAMED08800069203815 EUDAMED08800069203754 EUDAMED08800069203822 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
Procodile® 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sure Dent Corporation
- EUDAMED SRN
- KR-MF-000018662
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED a893cd22-7be0-490a-9d30-96c545be718b 61 fields · synced Jul 21, 2026
- EUDAMED 05defd6a-4b33-45d1-96e3-cb09a55e5086 61 fields · synced May 19, 2026
- EUDAMED 4b8f26ce-2734-4c91-ac79-71d2e9c6f5b6 61 fields · synced May 19, 2026
- EUDAMED c81d5aab-fb44-496b-9f72-82a1b99a964d 61 fields · synced May 19, 2026