BUN-ΟΥΡΙΑ R1:8x40, R2:4x20 ml (BS-300/380)

EUDAMED

Class IVD General (EU MDR)

Ref 001676

by Biotechnological Applications Ltd

Identity

Trade Name: BUN-ΟΥΡΙΑ R1:8x40, R2:4x20 ml (BS-300/380) EUDAMED
Device Name: BUN-ΟΥΡΙΑ R1:8x40, R2:4x20 ml (BS-300/380) EUDAMED
Model / Reference: 001676 EUDAMED

Identifiers

Primary DI / UDI-DI: 05213003192435 EUDAMED
Basic UDI-DI: B-05213003192435 EUDAMED
EMDN Code: W01010204 UREA/BLOOD UREA NITROGEN EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

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

BUN-ΟΥΡΙΑ R1:8x40, R2:4x20 ml (BS-300/380) by Biotechnological Applications Ltd — 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-05213003192435	Class IVD General	Active

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Manufacturer

Manufacturer: Biotechnological Applications Ltd
EUDAMED SRN: GR-MF-000033000

Sources (1)

EUDAMED 0408df49-7ccc-49cc-88a3-d4988cfcd597 61 fields · synced Jun 18, 2026