Identity
- Trade Name
- BlueLavage® EUDAMED
- Device Name
- BlueLavage® 2.0 EUDAMED
- Model / Reference
- BlueLavage® 2.0 EUDAMED102128 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260750250025 EUDAMED
- Basic UDI-DI
- 426075025011211BL2D EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Device sterilization/disinfection container, reusable
BlueLavage® by UTK Solution GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 01c1fb77-f2b5-414b-8b74-625511738919 61 fields · synced Jun 18, 2026