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Automated Glycohemoglobin Analyzer

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

Ref /Model AH-600 EMDN W0201050201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697553132023JR Basic UDI-DIDate12 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Automated Glycohemoglobin Analyzer
Model / Reference
AH-600, /
Primary DI / UDI-DI
06975531323222
Basic UDI-DI
697553132023JR
EMDN Code
W0201050201 High performance liquid chromatography systems
Device Class
Class A
Market of Registration
Finland

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
  • 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

Sources (1)

  • EUDAMED 96f9f584-d12e-4e89-bfea-b3b744c43db1 61 fields · synced 24 Oct 2026