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Strep A

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

Ref TFO-602

EMDN W0101060301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06936983140829 Basic UDI-DIDate5 Aug 2025RegisteredStatusActive

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
FOB Rapid Test
Model / Reference
TFO-602
Primary DI / UDI-DI
06936983140829, 06936983108591
Basic UDI-DI
B-06936983140829, B-06936983108591
EMDN Code
W0101060301 Guaiac-based faecal occult blood (cc)
Device Class
Class IVD General
Market of Registration
Germany

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
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (2)

  • EUDAMED 0920b3bb-0f2f-4710-b090-b9f15ae01ada 61 fields · synced 22 Oct 2026
  • EUDAMED 06936983108591|B-06936983108591 61 fields · synced 19 May 2026