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Urea/BUN – Liquizyme (UV)
EUDAMEDClass IVD General (EU MDR)
Ref 319 005Ref 319 001Ref 319 002Ref 319 004
Identity
- Trade Name
- Urea/BUN – Liquizyme (UV) EUDAMED
- Device Name
- Urea/BUN – Liquizyme (UV) EUDAMED
- Model / Reference
- 319 005 EUDAMED319 001 EUDAMED319 002 EUDAMED319 004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230041039718 EUDAMED62230041039336 EUDAMED62230041039404 EUDAMED62230041039640 EUDAMED
- Basic UDI-DI
- B-62230041039718 EUDAMEDB-62230041039336 EUDAMEDB-62230041039404 EUDAMEDB-62230041039640 EUDAMED
- EMDN Code
- W01010204 UREA/BLOOD UREA NITROGEN 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
Yes
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
Urea/BUN – Liquizyme (UV) 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-62230041039718 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000032599
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (4)
- EUDAMED 5151737f-75bd-44fa-9ad9-061cf54d06a6 61 fields · synced Oct 6, 2026
- EUDAMED b1050836-9c99-403b-9264-fa49f21a8be0 61 fields · synced May 16, 2026
- EUDAMED e6fcf9f7-453f-4098-a000-3445cc093e5a 61 fields · synced May 16, 2026
- EUDAMED 69fb4b7e-4c23-4d8b-9cf8-38d038b1df49 61 fields · synced May 18, 2026