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CAF Rapid Test Cassette (Urine)

EUDAMED

Class IVD General (EU MDR)

Ref acrCAF102R

by Acro Biotech Inc.

Identity

Trade Name
CAF Rapid Test Cassette (Urine) EUDAMED
Device Name
CAF Rapid Test Cassette (Urine) EUDAMED
Model / Reference
acrCAF102R EUDAMED

Identifiers

Primary DI / UDI-DI
D-acrCAF102RTL EUDAMED
Basic UDI-DI
B-acrCAF102RTL EUDAMED
EMDN Code
W0102160599 DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

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

CAF Rapid Test Cassette (Urine) by ACRO BIOTECH Inc. — 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

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Manufacturer

Manufacturer
Acro Biotech Inc.
EUDAMED SRN
US-MF-000017832
Authorised Representative
VidaQuick Biotech S.L. ES-AR-000048138

Sources (1)

  • EUDAMED 87deab35-4adb-4534-8953-06f3d1f4e712 61 fields · synced Aug 1, 2026