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G-Fill ISO
EUDAMEDClass IIa (EU MDR)
Ref ML55013 / 101-414Model GUTTA PERCHA POINTS ISO #80
Identity
- Trade Name
- G-Fill ISO EUDAMED
- Device Name
- GUTTA PERCHA POINTS EUDAMED
- Model / Reference
- GUTTA PERCHA POINTS ISO #80 EUDAMEDML55013 / 101-414 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806383574112 EUDAMED
- Basic UDI-DI
- B-08806383574112 EUDAMED
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
G-Fill ISO by Diadent Group International — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08806383574112 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Diadent Group International
- EUDAMED SRN
- KR-MF-000023806
- Authorised Representative
- Diadent Europe B.V. NL-AR-000012597
Sources (1)
- EUDAMED 42b34dc9-ce9c-46e7-95b5-dd570667cfcb 61 fields · synced Jun 19, 2026