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Lactate dehydrogenase (LDH)-Liquizyme (4+1)

EUDAMED

Class B (EU MDR)

Ref 238 004Ref 283 004

by Spectrum for Diagnostic Industries (Joint Stock Company)

Identity

Trade Name
Lactate dehydrogenase (LDH)-Liquizyme (4+1) EUDAMED
Device Name
Lactate dehydrogenase (LDH)-Liquizyme (4+1) EUDAMED
Model / Reference
238 004 EUDAMED
283 004 EUDAMED

Identifiers

Primary DI / UDI-DI
G458283004A7 EUDAMED
Basic UDI-DI
++G458283N8 EUDAMED
EMDN Code
W01010120 LACTATE DEHYDROGENASE P ( LDH - P --> L ) EUDAMED

Classification

Device Class
Class B EUDAMED
Market of Registration
Germany EUDAMED
France 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

New Device

No

EUDAMED

Lactate dehydrogenase (LDH)-Liquizyme (4+1) by Spectrum for Diagnostic Industries (Joint Stock Company) — Class B — IVDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

EUDAMED SRN
EG-MF-000033954
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (2)

  • EUDAMED 00272df8-bcd3-4857-b12b-e7e536a845e1 61 fields · synced Jun 19, 2026
  • EUDAMED 7ef3dfa9-ae1b-43f9-bddf-7870168853e8 61 fields · synced Jun 19, 2026