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ß-THALASSAEMIA & HbA1c Assay Column(HPLC)

by Shenzhen Lifotronic Technology Co., Ltd. 3 variants

Ref 032020602Model H8, H9, H100

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 linked in EUDAMED

A group certificate may exist

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/IVDR Number6970341680120202GS Basic UDI-DI 06978139072653UDI-DIDate11 Dec 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
H8, H9, H100, 032020602
Primary DI / UDI-DI
06978139072653
Basic UDI-DI
6970341680120202GS
EMDN Code
W0201050280 High performance liquid chromatography systems - hardware accessories
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000005654
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing
  • New Device

Other properties (7)

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