Identity
- Trade Name
- BL2001.1 DriveUnit EUDAMED
- Device Name
- BlueLavage® EUDAMED
- Model / Reference
- BlueLavage® EUDAMED101296 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260750250094 EUDAMED
- Basic UDI-DI
- 426075025011211BL2D EUDAMED
- Direct Marketing DI
- 04260750250094 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
BL2001.1 DriveUnit by UTK Solution GmbH — Class IIa — 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 | 426075025011211BL2D | Class IIa | Active |
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Manufacturer
- Manufacturer
- UTK Solution GmbH
- EUDAMED SRN
- DE-MF-000013399
Sources (1)
- EUDAMED 71ea1373-5c5f-4527-af4c-35ffcfdd368f 61 fields · synced Jul 18, 2026