Identity
- Trade Name
- Coltene Bioscience UC40 EUDAMED
- Device Name
- Ultrasonic Cleaner EUDAMED
- Model / Reference
- 60021961 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +E165600210610 EUDAMED
- Basic UDI-DI
- 1506049385UltrasonicJ6 EUDAMED
- EMDN Code
- D0801 ENZYMATIC DETERGENTS FOR MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Coltene Bioscience UC40 by Topdental (Products) Ltd — 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 | 1506049385UltrasonicJ6 | Class I | Active |
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Manufacturer
- Manufacturer
- Topdental (Products) Ltd
- EUDAMED SRN
- GB-MF-000003937
- Authorised Representative
- Directa AB SE-AR-000002492
Sources (1)
- EUDAMED a7f45951-9bf1-4df9-b352-7cd3ceef24e1 61 fields · synced Jul 9, 2026