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D-Roms Lab 50

EUDAMED

Class IVD General (EU MDR)

Ref DROLAB50Model d-ROMs

by H & D S.r.l.

Identity

Trade Name: D-ROMS LAB 50 EUDAMED
Device Name: D-ROMS LAB 50 EUDAMED
Model / Reference: d-ROMs EUDAMED
DROLAB50 EUDAMED

Identifiers

Primary DI / UDI-DI: 08050247770114 EUDAMED
Basic UDI-DI: B-08050247770114 EUDAMED
EMDN Code: W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED

Classification

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

Category: Nucleic acid extraction/isolation kit IVD

D-Roms Lab 50 by H & D S.r.l. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

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Also classified as Nucleic acid extraction/isolation kit IVD.

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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer: H & D S.r.l.
EUDAMED SRN: IT-MF-000036620

Sources (1)

EUDAMED 16559b52-e6c9-4907-a4f2-a859329b8315 61 fields · synced Jul 16, 2026