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Wellsamed Guttapercha Points
EUDAMEDClass IIa (EU MDR)
Ref WGP330 ISO30 BlauRef WGP325 ISO25 RotRef WGP420 ISO20 GelbRef WGP620 ISO20 Gelb
Identity
- Trade Name
- Wellsamed Guttapercha Points EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- WGP330 ISO30 Blau EUDAMEDWGP325 ISO25 Rot EUDAMEDWGP420 ISO20 Gelb EUDAMEDWGP620 ISO20 Gelb EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069206878 EUDAMED08800069206861 EUDAMED08800069206991 EUDAMED08800069207073 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069206878 EUDAMED08800069206861 EUDAMED08800069206991 EUDAMED08800069207073 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
Wellsamed 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 (4)
- EUDAMED efad8720-c4d9-4722-b03c-596a4480ae44 61 fields · synced Sep 18, 2026
- EUDAMED 2a3a422f-e81c-4a91-a882-084d1dace822 61 fields · synced May 17, 2026
- EUDAMED e454a245-48f3-4785-96d1-b806c55ad54d 61 fields · synced May 18, 2026
- EUDAMED fd053d10-c3e1-4043-9418-7e5f9e8f7856 61 fields · synced May 19, 2026