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BioSonic Super Concentrate General Purpose Cleaning
EUDAMEDFDA UDIClass I (EU MDR)
Ref UC30
Identity
- Trade Name
- BioSonic Super Concentrate General Purpose Cleaning EUDAMEDBioSonic FDA UDI
- Generic Name
- Ultrasonic-cleaning water bath FDA UDI
- Device Name
- BioSonic Cleaning Solutions EUDAMEDGeneral Purpose Solution FDA UDI
- Model / Reference
- UC30 EUDAMEDFDA UDI
- Description
- General Purpose Solution FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661UC300 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 Super Concentrate General Purpose Cleaning 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 1d05a0cf-239d-4ae1-acb1-426eefcfc293 61 fields · synced Jul 9, 2026
- FDA UDI 035b5525-761c-4135-b5a4-7e4b3e0b90c9 33 fields · synced May 30, 2026