Skip to content

Beta-Thalassemia Analysis Kits ( HPLC )

by AILEX(Hunan)Medical Equipment Co., Ltd. China EUDAMED

Ref /Model 150Tests EMDN W0103010202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975531323635 Basic UDI-DIDate23 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Beta-Thalassemia Analysis Kits ( HPLC )
Model / Reference
150Tests, /
Primary DI / UDI-DI
06975531323635
Basic UDI-DI
B-06975531323635
EMDN Code
W0103010202 Haemoglobin subtypes hba2, hbc, hbf, hbs, etc.(excl. hba1)
Device Class
Class IVD General
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000043377
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from AILEX(Hunan)Medical Equipment Co., Ltd.

See all devices from AILEX(Hunan)Medical Equipment Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED eb4f2188-f986-4af0-b3d5-d7b208000071 61 fields · synced 24 Oct 2026