Identity
- Trade Name
- Kera NH EUDAMED
- Device Name
- Kera N, Kera NH, Kera C, Keragen, Main Metall EUDAMED
- Model / Reference
- 1004020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDWA10040201 EUDAMED
- Basic UDI-DI
- ++EDWAAUFNEM6D EUDAMED
- EMDN Code
- Q010601 DENTAL ALLOYS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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: Dental casting non-noble alloy
Kera NH by Eisenbacher Dentalwaren Ed 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 | ++EDWAAUFNEM6D | Class IIa | Active |
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Manufacturer
- Manufacturer
- Eisenbacher Dentalwaren ED GmbH
- EUDAMED SRN
- DE-MF-000008322
Sources (1)
- EUDAMED f1ac9a4d-fd23-4e52-a2f7-2bdfaba6d5bf 61 fields · synced Jul 31, 2026