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Urea/BUN – single reagent
EUDAMEDClass IVD General (EU MDR)
Ref 320 003Ref 320 001
Identity
- Trade Name
- Urea/BUN – single reagent EUDAMED
- Device Name
- Urea/BUN – single reagent EUDAMED
- Model / Reference
- 320 003 EUDAMED320 001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230041038278 EUDAMED62230041038032 EUDAMED
- Basic UDI-DI
- B-62230041038278 EUDAMEDB-62230041038032 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 – 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-62230041038278 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000032599
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 85e23bee-f337-4f83-a4f0-c3a09204585e 61 fields · synced Oct 6, 2026
- EUDAMED 76449d7b-0338-40a6-9c1a-75407640cd37 61 fields · synced May 17, 2026