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Direct Gutta Percha Points
EUDAMEDClass IIa (EU MDR)
Ref 200006Ref 200026Ref 200025Ref 200020Ref 200009Ref 200001Ref 200007Ref 200008Ref 200021Ref 200005Ref 200012Ref 200013
Identity
- Trade Name
- Direct Gutta Percha Points EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- 200006 EUDAMED200026 EUDAMED200025 EUDAMED200020 EUDAMED200009 EUDAMED200001 EUDAMED200007 EUDAMED200008 EUDAMED200021 EUDAMED200005 EUDAMED200012 EUDAMED200013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069205826 EUDAMED08800069206021 EUDAMED08800069206014 EUDAMED08800069205963 EUDAMED08800069205857 EUDAMED08800069205772 EUDAMED08800069205833 EUDAMED08800069205840 EUDAMED08800069205970 EUDAMED08800069205819 EUDAMED08800069205888 EUDAMED08800069205895 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069205826 EUDAMED08800069206021 EUDAMED08800069206014 EUDAMED08800069205963 EUDAMED08800069205857 EUDAMED08800069205772 EUDAMED08800069205833 EUDAMED08800069205840 EUDAMED08800069205970 EUDAMED08800069205819 EUDAMED08800069205888 EUDAMED08800069205895 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
Direct Gutta Percha 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 (12)
- EUDAMED 1bf07378-375d-4f53-9699-5cd070105425 61 fields · synced Aug 4, 2026
- EUDAMED 15ad4467-5354-4271-a52a-ea5543714905 61 fields · synced May 11, 2026
- EUDAMED a6a2c140-650f-4ffa-a27a-176643d27fcd 61 fields · synced May 17, 2026
- EUDAMED f116b557-e8f9-4df0-841c-1f2436e372bf 61 fields · synced May 17, 2026
- EUDAMED 93318708-d8d8-48e9-baaf-89bef93d16ac 61 fields · synced May 17, 2026
- EUDAMED 2c1cd5c6-b588-4be5-8495-755f61460525 61 fields · synced May 17, 2026
- EUDAMED 983ce373-523f-4d23-8351-7dfdb826ecde 61 fields · synced May 17, 2026
- EUDAMED ea027dc5-427c-4814-ab23-e087f2a2fb53 61 fields · synced May 18, 2026
- EUDAMED df14cf47-ed8e-4386-862c-cb3e71bcaf14 61 fields · synced May 18, 2026
- EUDAMED b3d68cd1-61d7-4f4d-b269-5658dd38089a 61 fields · synced May 18, 2026
- EUDAMED 055386fe-8555-4485-9eeb-5afcc2e30f9b 61 fields · synced May 19, 2026
- EUDAMED 09fe5c4a-df22-4de9-aa13-87075352cd58 61 fields · synced May 19, 2026