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β2-MG Quantitative Test Kit (Time-Resolved FIA)

EUDAMED

Class IVD General (EU MDR)

Ref FIMG-402a

by Healgen Scientific Limited Liability Company

Identity

Trade Name
β2-MG Quantitative Test Kit (Time-Resolved FIA) EUDAMED
Model / Reference
FIMG-402a EUDAMED

Identifiers

Primary DI / UDI-DI
D-FIMG-402aHGRE EUDAMED
Basic UDI-DI
B-FIMG-402aHGRE EUDAMED
EMDN Code
W0102039002 BETA2-MICROGLOBULIN 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

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Category: Beta-2-microglobulin IVD, reagent

β2-MG Quantitative Test Kit (Time-Resolved FIA) by Healgen Scientific Limited Liability Company — Class IVD General — IVDD — listed in EUDAMED

Similar devices

Also classified as Beta-2-microglobulin IVD, reagent.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Healgen Scientific Limited Liability Company
EUDAMED SRN
US-MF-000018839
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (1)

  • EUDAMED bb0129ee-6803-483d-9477-f90e0409df3f 61 fields · synced Jul 23, 2026