Identity
- Trade Name
- UC300-230V Ultrasonic Cleaner EUDAMED
- Device Name
- BioSonic Ultrasonic Cleaners EUDAMED
- Model / Reference
- UC300230CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- D661UC300230CE0 EUDAMED
- Basic UDI-DI
- ++D661043KK EUDAMED
- EMDN Code
- Z12011302 ULTRASONIC CLEANING EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
UC300-230V 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 7ebf8883-312b-4ac4-bf61-16c44aed6f2c 61 fields · synced Jul 11, 2026