Identity
- Device Name
- GEFMTA400 EUDAMED
- Model / Reference
- 76630 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EPLS766300 EUDAMED
- Basic UDI-DI
- ++EPLSGEFMTA400JV EUDAMED
- EMDN Code
- Q01010202 ROOT CANAL FILLING DENTAL CEMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
Category: Calcium hydroxide dental cement
Gefmta400 by P.L. Superior Dental Materials GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | ++EPLSGEFMTA400JV | Class IIa | Active |
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Manufacturer
- Manufacturer
- P.L. Superior Dental Materials GmbH
- EUDAMED SRN
- DE-MF-000005251
Sources (1)
- EUDAMED ba2c6998-9090-431f-b55e-7d5899d8ad5b 61 fields · synced Jul 12, 2026