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Immunoglobulin M (IgM) Assay Reagent Kit (Immunoturbidimetric)

by Rayto Life and Analytical Sciences Co., Ltd. 6 variants

Ref R06814Model R1: 45mL×2, R2: 15mL×2; 1×1mL

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

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-R0681434 Basic UDI-DI D-R0681434UDI-DIDate10 Jun 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  • Withdrawn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

Device Name
Immunoglobulin M (IgM) Assay Reagent Kit (Immunoturbidimetric)
Model / Reference
R1: 45mL×2, R2: 15mL×2, 1×1mL, R06814
Primary DI / UDI-DI
D-R0681434
Basic UDI-DI
B-R0681434
EMDN Code
W0102010107 Immunoglobulin m
Device Class
Class IVD General
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000011141
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Rayto Life and Analytical Sciences Co., Ltd.

See all devices from Rayto Life and Analytical Sciences Co., Ltd. →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

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