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THALASSAEMIA & HbA1c Reagent Kit (HPLC)

by Shenzhen Lifotronic Technology Co., Ltd. 2 variants

Ref 0320201206Model 200T, 400T

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 Number69703416803202026HQ Basic UDI-DI 06975984066073UDI-DIDate24 Oct 2025RegisteredStatusActive

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  • Withdrawn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

Model / Reference
200T, 400T, 0320201206
Primary DI / UDI-DI
06975984066073
Basic UDI-DI
69703416803202026HQ
EMDN Code
W0103010299 Other haemoglobin (types) testing - other
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000005654
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

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Properties

  • Reagent
  • Professional Testing

Other properties (9)

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