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Ap-10

by Leison Biotech Co., Ltd. Taiwan EUDAMED

Ref N/AModel AP-10

EMDN W0101060101,W010106010801,W0201060102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-471987421AP-108W8C Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Blood Glucose Monitoring System
Model / Reference
AP-10, N/A
Primary DI / UDI-DI
D-471987421AP-108W8C
Basic UDI-DI
B-471987421AP-108W8C
EMDN Code
W0101060101,W010106010801,W0201060102
Device Class
Class IVD devices for self-testing
Market of Registration
France

Manufacturer details

EUDAMED SRN
TW-MF-000026417
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Leison Biotech Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Self Testing
  • Surgical Instrument
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED 8b6816ba-ad64-4cdf-b2c1-53ff89de9b85 61 fields · synced 22 Oct 2026