Identity
- Trade Name
- BURNISHER SCALER 2.5mm/3.0mm EUDAMED
- Device Name
- BURNISHER SCALER 2.5mm/3.0mm EUDAMED
- Model / Reference
- 1019-7 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D123101970 EUDAMED
- Basic UDI-DI
- ++D12310197C6 EUDAMED
- EMDN Code
- L159003 DENTAL AND PERIODONTAL PROBES AND EXPLORERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
BURNISHER SCALER 2.5mm/3.0mm by Dental Expert — 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 | ++D12310197C6 | Class I | Active |
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Manufacturer
- Manufacturer
- Dental Expert
- EUDAMED SRN
- PK-MF-000024595
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED 7d8b76fa-7a79-40d7-a911-b596cc9b57ca 61 fields · synced Jun 19, 2026