Identity
- Trade Name
- UC50 240V Ultrasonic Cleaner EUDAMED
- Device Name
- BioSonic Ultrasonic Cleaners EUDAMED
- Model / Reference
- UC50DB240 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D661UC50DB2400 EUDAMED
- Basic UDI-DI
- ++D661043KK EUDAMED
- EMDN Code
- Z12011302 ULTRASONIC CLEANING EQUIPMENT 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
UC50 240V Ultrasonic Cleaner by Coltene/Whaledent Inc. — 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 | ++D661043KK | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
- EUDAMED SRN
- US-MF-000015761
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (1)
- EUDAMED c7add132-1c19-43c4-8c1f-0fc50878d27a 61 fields · synced Jun 18, 2026