Identity
- Trade Name
- UC300 Basket Section Inserts EUDAMEDBioSonic FDA UDI
- Generic Name
- Ultrasonic-cleaning water bath FDA UDI
- Device Name
- BioSonic Ultrasonic Cleaners EUDAMED2 Basket Section Inserts FDA UDI
- Model / Reference
- UC335 EUDAMEDFDA UDI
- Description
- 2 Basket Section Inserts FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661UC3351 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
UC300 Basket Section Inserts 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 da5034bc-cc5e-4711-acb4-c981b338d3b7 61 fields · synced Jul 9, 2026
- FDA UDI c38437c1-dc0f-4fb1-bfd8-400b98dde4f2 33 fields · synced May 30, 2026