Identity
- Trade Name
- SCALER 204SD EUDAMED
- Device Name
- SCALER 204SD EUDAMED
- Model / Reference
- 1013-46B EUDAMED1013-46 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D123101346B0 EUDAMEDD1231013460 EUDAMED
- Basic UDI-DI
- ++D123101346BH5 EUDAMED++D123101346W7 EUDAMED
- EMDN Code
- L159001 DENTAL AND PERIODONTAL CURETTES, 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
Scaler 204sd 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 | ++D123101346BH5 | 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 (2)
- EUDAMED 8c19e219-ddc8-4044-a1be-6f0500642a66 61 fields · synced Jul 20, 2026
- EUDAMED 5318b464-1339-4d83-a488-15363740cf39 61 fields · synced May 17, 2026