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Immunoglobulin M Test Kit (Immunoturbidimetric Assay)

by URIT Medical Electronic Co., Ltd.

Ref "REF: U88482040M, U88489060M, U88485020M, U88411020M, U88420060M"

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Overview

The Immunoglobulin M Test Kit (Immunoturbidimetric Assay) is a highly accurate and reliable device for detecting Immunoglobulin M antibodies in human serum. It provides precise results for diagnostic purposes, ensuring accurate identification of patients with IgM-related conditions.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-6-36AF Basic UDI-DI D-6-36AFUDI-DIDate21 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
"REF: U88482040M, U88489060M, U88485020M, U88411020M, U88420060M"
Primary DI / UDI-DI
D-6-36AF
Basic UDI-DI
B-6-36AF
EMDN Code
W0102010107 Immunoglobulin m
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000011840
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No