Identity
- Trade Name
- Amalgamentferner EUDAMED
- Device Name
- HM-/Stahl-Bohrer EUDAMED
- Model / Reference
- 10521 EUDAMEDH31A.314.012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E312H31A3140121 EUDAMED
- Basic UDI-DI
- ++E31210521CQ EUDAMED
- Unit of Use DI
- E312H31A314012101 EUDAMED
- EMDN Code
- L159007 ODONTOSTOMATOLOGY BURS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Liechtenstein EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Amalgamentferner by Edenta Etablissement — 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 | ++E31210521CQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Edenta Etablissement
- EUDAMED SRN
- LI-MF-000011937
Sources (1)
- EUDAMED 877ebc19-a515-4006-9005-76536c63bb67 61 fields · synced Jun 18, 2026