Skip to content

Erythrocyte Sedimentation Rate Analyzer

by Shinwha Medi Co., Ltd.

Ref easy M30

Active European Union

CE IVDR

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880010970003A7 Basic UDI-DI 08800109700038UDI-DIDate10 Oct 2024RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
Erythrocyte Sedimentation Rate Analyzer
Model / Reference
easy M30
Primary DI / UDI-DI
08800109700038
Basic UDI-DI
880010970003A7
Direct Marketing DI
08800109700038
EMDN Code
W02029001 Erythrocyte sedimentation rate devices
Device Class
Class A
EU market of registration
Croatia

Manufacturer details

EUDAMED SRN
KR-MF-000044090
Authorised representative
Advena Limited MT-AR-000000234

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No