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ALT/Hb for Blood Donation Screen Tests

by Diasia Biomedical Technology Co., Ltd. China EUDAMED

Ref R231062, R231050, R231051, R231052Model 50 Tests/kit, 10 Tests/kit, 25 Tests/kit EMDN W0101060109

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06973316741131 Basic UDI-DIDate8 Dec 2025RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
ALT/Hb for Blood Donation Screen Tests
TG/ALT/Hb for Blood Donation Screen Tests
Model / Reference
50 Tests/kit, R231062, 10 Tests/kit, R231050, 25 Tests/kit, R231051, R231052
Primary DI / UDI-DI
06973316741131, 06973316741414, 06973316741421, 06973316741438
Basic UDI-DI
B-06973316741131, B-06973316741414, B-06973316741421, B-06973316741438
EMDN Code
W0101060109 Multiple parameter blood test
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000010281
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Diasia Biomedical Technology Co., Ltd.

See all devices from Diasia Biomedical Technology 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 (4)

  • EUDAMED 57043cc8-8d24-4611-9233-17cf857e25f3 61 fields · synced 22 Oct 2026
  • EUDAMED 06973316741414|B-06973316741414 61 fields · synced 17 May 2026
  • EUDAMED 06973316741421|B-06973316741421 61 fields · synced 18 May 2026
  • EUDAMED 06973316741438|B-06973316741438 61 fields · synced 19 May 2026