Identity
- Trade Name
- UC50 Instrument Basket EUDAMED
- Device Name
- BioSonic Ultrasonic Cleaners EUDAMED
- Model / Reference
- UC58 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D661UC580 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
UC50 Instrument Basket 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 |
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Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
- EUDAMED SRN
- US-MF-000015761
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (1)
- EUDAMED de9c8bac-62ef-4e08-916b-5a643c075507 61 fields · synced Jun 19, 2026