Skip to content

Small Dense Low Density Lipoprotein-Cholesterol (sdLDL-C) Assay Kit (Peroxidase Method)

by URIT Medical Electronic Co., Ltd.

Ref "REF: USCA00000730 USCA00000728,USCA00000729 USCA00000731,USCA00000772 USCA00000773"

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-6-128FN Basic UDI-DI D-6-128FNUDI-DIDate22 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  • Withdrawn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

Device Name
Small Dense Low Density Lipoprotein-Cholesterol (sdLDL-C) Assay Kit (Peroxidase Method)
Model / Reference
"REF: USCA00000730 USCA00000728, USCA00000729 USCA00000731, USCA00000772 USCA00000773"
Primary DI / UDI-DI
D-6-128FN
Basic UDI-DI
B-6-128FN
EMDN Code
W01010221 Low density lipoprotein cholesterol including sd-ldl
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

Other devices from URIT Medical Electronic Co., Ltd.

See all devices from URIT Medical Electronic Co., Ltd. →

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