Urea/BUN - LS (Modified Urease-Berthlot Method)

EUDAMED

Class IVD General (EU MDR)

Ref 321 001

by Egyptian Company For Biotechnology-Spectrum Diagnostics

Identity

Trade Name: Urea/BUN - LS (Modified Urease-Berthlot Method) EUDAMED
Device Name: Urea/BUN - LS (Modified Urease-Berthlot Method) EUDAMED
Model / Reference: 321 001 EUDAMED

Identifiers

Primary DI / UDI-DI: 62230041038964 EUDAMED
Basic UDI-DI: B-62230041038964 EUDAMED
EMDN Code: W01010204 UREA/BLOOD UREA NITROGEN EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Urea/BUN - LS (Modified Urease-Berthlot Method) by Egyptian Company For Biotechnology-Spectrum Diagnostics — Class IVD General — CE/MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	B-62230041038964	Class IVD General	Active

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Manufacturer

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
EUDAMED SRN: EG-MF-000032599
Authorised Representative: MDSS GmbH DE-AR-000005430

Sources (1)

EUDAMED 30943785-d9e0-4ab6-ac4f-f2eb4ab0f616 61 fields · synced Oct 6, 2026