Identity
- Trade Name
- DGU-20A5R CL EUDAMED
- Device Name
- Solvent Delivery Module EUDAMED
- Model / Reference
- 228-45019-55 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540217420254 EUDAMED
- Basic UDI-DI
- B-04540217420254 EUDAMED
- EMDN Code
- W0201050201,W020303 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Dgu-20a5r Cl by Shimadzu Corporation — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-04540217420254 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shimadzu Corporation
- EUDAMED SRN
- JP-MF-000025145
- Authorised Representative
- Shimadzu Europa GmbH DE-AR-000013563
Sources (1)
- EUDAMED abe93ad6-975a-48a3-9bbb-8e93a264f661 61 fields · synced Jul 11, 2026