Identity
- Trade Name
- Bilirubin Total - single reagent EUDAMED
- Device Name
- Bilirubin Total - single reagent EUDAMED
- Model / Reference
- 223 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230041035444 EUDAMED
- Basic UDI-DI
- B-62230041035444 EUDAMED
- EMDN Code
- W01010203 BILIRUBIN 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Bilirubin Total - single reagent by Egyptian Company For Biotechnology-Spectrum Diagnostics — Class IVD General — IVDD — listed in EUDAMED
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-62230041035444 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000032599
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED c2c4c18e-c660-4173-9127-412df6be1b10 61 fields · synced Jun 20, 2026