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TSH Rapid Test Cassette

by Hangzhou Alltest Biotech.Co., Ltd. China EUDAMED

Ref OTS-402H EMDN W0102160903

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06936983100144 Basic UDI-DIDate23 Feb 2023RegisteredStatusActive

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  • Withdrawn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

Model / Reference
OTS-402H
Primary DI / UDI-DI
06936983100144, 06942598246986, 06936983120456
Basic UDI-DI
B-06936983100144, B-06942598246986, B-06936983120456
EMDN Code
W0102160903 Thyroid-stimulating hormone - rt & poc
Device Class
Class IVD devices for self-testing
Market of Registration
Germany
Ireland
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000010710
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Hangzhou Alltest Biotech.Co., Ltd.

See all devices from Hangzhou Alltest Biotech.Co., Ltd. →

Properties & raw data

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

Sources (3)

  • EUDAMED b1376f31-5169-4101-a862-4f0aeb58aa7b 61 fields · synced 22 Oct 2026
  • EUDAMED 06942598246986|B-06942598246986 61 fields · synced 16 Oct 2026
  • EUDAMED 06936983120456|B-06936983120456 61 fields · synced 16 Oct 2026