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FQ Guttapercha Points
EUDAMEDClass IIa (EU MDR)
Ref GPFQ04.000.025Ref GPFQ04.000.045Ref GPFQ06.000.030Ref GPFQ04.000.030Ref GPFQ06.000.025Ref GPFQ04.000.035Ref GPFQ06.000.020
Identity
- Trade Name
- FQ Guttapercha Points EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- GPFQ04.000.025 EUDAMEDGPFQ04.000.045 EUDAMEDGPFQ06.000.030 EUDAMEDGPFQ04.000.030 EUDAMEDGPFQ06.000.025 EUDAMEDGPFQ04.000.035 EUDAMEDGPFQ06.000.020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069204188 EUDAMED08800069204218 EUDAMED08800069204256 EUDAMED08800069204195 EUDAMED08800069204249 EUDAMED08800069204201 EUDAMED08800069204232 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069204188 EUDAMED08800069204218 EUDAMED08800069204256 EUDAMED08800069204195 EUDAMED08800069204249 EUDAMED08800069204201 EUDAMED08800069204232 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
FQ 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 (7)
- EUDAMED 8a8c101e-4ac0-442a-93c7-c20b8b771b8d 61 fields · synced Sep 18, 2026
- EUDAMED c0f69021-af11-43b8-9de4-5ae902967bfc 61 fields · synced May 16, 2026
- EUDAMED f0cb1024-32cd-4ebd-90c5-744776987a05 61 fields · synced May 18, 2026
- EUDAMED 5b82d3f7-5948-46df-8979-84d02bbc6053 61 fields · synced May 19, 2026
- EUDAMED 4953aff1-3fd4-484c-ad5c-595fd3e46791 61 fields · synced May 19, 2026
- EUDAMED b2cae796-19e3-4175-bd07-13b1ecbc4ad5 61 fields · synced May 19, 2026
- EUDAMED 7e1956c9-ad6f-495e-8c20-3640b542a0b3 61 fields · synced May 19, 2026