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Optilite® Beta-2 Microglobulin Urine Kit

EUDAMED

Class B (EU MDR)

Ref LK043.L.OPT

by The Binding Site Group Ltd

Identity

Trade Name
Optilite® Beta-2 Microglobulin Urine Kit EUDAMED
Device Name
Optilite® Beta-2 Microglobulin Urine Kit EUDAMED
Model / Reference
LK043.L.OPT EUDAMED

Identifiers

Primary DI / UDI-DI
05051700017350 EUDAMED
Basic UDI-DI
5051700LK043.L.OPTJL EUDAMED
EMDN Code
W0102039002 BETA2-MICROGLOBULIN EUDAMED

Classification

Device Class
Class B EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

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

New Device

No

EUDAMED

Category: Beta-2-microglobulin IVD, reagent

Optilite® Beta-2 Microglobulin Urine Kit by The Binding Site Group Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
The Binding Site Group Ltd
EUDAMED SRN
UK-MF-000036707
Authorised Representative
The Binding Site Ireland Limited IE-AR-000034426

Sources (1)

  • EUDAMED cda7b27a-b623-459f-812c-6134800d4920 61 fields · synced Aug 3, 2026