Identity
- Trade Name
- UC150 Cassette Basket EUDAMEDBioSonic FDA UDI
- Generic Name
- Ultrasonic-cleaning water bath FDA UDI
- Device Name
- BioSonic Ultrasonic Cleaners EUDAMEDUC150 Casset Basket FDA UDI
- Model / Reference
- 60022040 EUDAMEDFDA UDI
- Description
- UC150 Casset Basket FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661600220400 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D661043KK EUDAMED
- FDA Product Code
- FLG FDA UDI
- EMDN Code
- Z12011302 ULTRASONIC CLEANING EQUIPMENT EUDAMED
- GMDN Term
- Ultrasonic-cleaning water bath FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6150 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
UC150 Cassette Basket by Coltene/Whaledent Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D661043KK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED bccf6578-6d63-4b58-8383-8fb6e8292ef5 61 fields · synced Jul 10, 2026
- FDA UDI fcfe1c2c-d7c8-4c06-a81c-edd2d63d2992 33 fields · synced May 30, 2026