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Hemoglobin Analyzer(HPLC)

by Shenzhen Lifotronic Technology Co., Ltd. EUDAMED

Active European Union

Ref 0120215Model H6, H8, H9, H100, H100Plus, 96TH, A10TH, A10,

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6970341680120203GU Basic UDI-DIDate17 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
H6, H8, H9, H100, H100Plus, 96TH, A10TH, A10, 0120215
Primary DI / UDI-DI
06970341680237, 06975984066431
Basic UDI-DI
6970341680120203GU
Direct Marketing DI
06970341680237
EMDN Code
W0201060101, W0201050201
Device Class
Class A
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

  • 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