Identity
- Trade Name
- GUTTA PERCHA - STANDARD 45-80 EUDAMED
- Device Name
- GUTTA PERCHA EUDAMED
- Model / Reference
- PRD.01.GN01-45-80 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260296270587 EUDAMED
- Basic UDI-DI
- 426029627GPP0015U 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
Gutta Percha - Standard 45-80 by President Dental GmbH — 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 | 426029627GPP0015U | Class IIa | Active |
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Manufacturer
- Manufacturer
- President Dental GmbH
- EUDAMED SRN
- DE-MF-000014901
Sources (1)
- EUDAMED 52d70129-ff40-47da-be49-9687c7b65f7d 61 fields · synced Jun 19, 2026