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BioSonic Enzymatic Ultrasonic Cleaning Solution Concentrate
EUDAMEDFDA UDIClass I (EU MDR)
Ref UC32
Identity
- Trade Name
- BioSonic Enzymatic Ultrasonic Cleaning Solution Concentrate EUDAMEDBioSonic FDA UDI
- Generic Name
- Ultrasonic-cleaning water bath FDA UDI
- Device Name
- BioSonic Cleaning Solutions EUDAMEDEnzymatic Solution FDA UDI
- Model / Reference
- UC32 EUDAMEDFDA UDI
- Description
- Enzymatic Solution FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661UC320 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D661082KV EUDAMED
- FDA Product Code
- FLG FDA UDI
- EMDN Code
- D0899 DETERGENTS FOR MEDICAL DEVICES - OTHER 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
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
BioSonic Enzymatic Ultrasonic Cleaning Solution Concentrate by Coltene/Whaledent Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | ++D661082KV | 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 7a9a287e-2353-4a7d-9f19-54b02c60471a 61 fields · synced Jun 18, 2026
- FDA UDI cd462e11-52e5-45dd-8f0a-73845aca3d00 33 fields · synced May 30, 2026