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GuttaPercha Points
EUDAMEDClass IIa (EU MDR)
Ref GP02.000.015Ref GP02.000.040Ref GP02.000.035Ref GP04.000.015Ref GP04.000.020Ref GP02.000.S1Ref GP04.000.025Ref GP04.000.035Ref GP02.000.020
Identity
- Trade Name
- GuttaPercha Points EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- GP02.000.015 EUDAMEDGP02.000.040 EUDAMEDGP02.000.035 EUDAMEDGP04.000.015 EUDAMEDGP04.000.020 EUDAMEDGP02.000.S1 EUDAMEDGP04.000.025 EUDAMEDGP04.000.035 EUDAMEDGP02.000.020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069203976 EUDAMED08800069204027 EUDAMED08800069204010 EUDAMED08800069203914 EUDAMED08800069203921 EUDAMED08800069204034 EUDAMED08800069203938 EUDAMED08800069203952 EUDAMED08800069203983 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069203976 EUDAMED08800069204027 EUDAMED08800069204010 EUDAMED08800069203914 EUDAMED08800069203921 EUDAMED08800069204034 EUDAMED08800069203938 EUDAMED08800069203952 EUDAMED08800069203983 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
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 |
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Manufacturer
- Manufacturer
- Sure Dent Corporation
- EUDAMED SRN
- KR-MF-000018662
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (9)
- EUDAMED 4fb52bce-ec7c-4571-bb99-43aff19e8d97 61 fields · synced Aug 4, 2026
- EUDAMED d357f2ef-9459-42b4-9bac-f59e81b952b3 61 fields · synced May 16, 2026
- EUDAMED 011f9c45-1ae5-47a8-9dd0-deea7e970d37 61 fields · synced May 17, 2026
- EUDAMED a9bb8710-59f6-4735-a1f6-b232a036bfd3 61 fields · synced May 17, 2026
- EUDAMED aba9cf3d-860d-48fb-a445-11bc0597bcaa 61 fields · synced May 17, 2026
- EUDAMED b1406e37-3b76-43d9-89c5-316374645d11 61 fields · synced May 18, 2026
- EUDAMED 135c23bf-aa01-4f25-8b2c-a7a3816ff32b 61 fields · synced May 18, 2026
- EUDAMED 7475d96b-15b7-45ea-901c-8af0a1a706b2 61 fields · synced May 18, 2026
- EUDAMED 4c4c2920-ef2d-4eba-9b07-002be6809b4e 61 fields · synced May 18, 2026