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Iso Coloured
EUDAMEDClass IIa (EU MDR)
Ref 47907 / 101-S609Model GUTTA PERCHA POINTS ISO #45
Identity
- Trade Name
- ISO COLOURED EUDAMED
- Device Name
- GUTTA PERCHA POINTS EUDAMED
- Model / Reference
- GUTTA PERCHA POINTS ISO #45 EUDAMED47907 / 101-S609 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806383533508 EUDAMED
- Basic UDI-DI
- B-08806383533508 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
Iso Coloured 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-08806383533508 | 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 d4e8cff0-c3fe-4e1f-8da4-233dafaca26a 61 fields · synced Jul 23, 2026