Identity
- Trade Name
- edisonite classic dental EUDAMED
- Device Name
- edisonite classic EUDAMED
- Model / Reference
- 231050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04032651310500 EUDAMED
- Basic UDI-DI
- 4032651BSC00000057AP EUDAMED
- EMDN Code
- D0899 DETERGENTS FOR MEDICAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
edisonite classic dental by Schülke & Mayr GmbH — Class I — 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 | 4032651BSC00000057AP | Class I | Active |
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Manufacturer
- Manufacturer
- Schülke & Mayr GmbH
- EUDAMED SRN
- DE-MF-000005701
Sources (1)
- EUDAMED cf61a735-cf1f-4bd6-ae1f-be0acda3444b 61 fields · synced Oct 6, 2026