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AI Morphology analyzer

by Seamaty Diagnostic Technology (Chengdu) Co., Ltd. China EUDAMED

Ref A00500000EN0Model SA1 EMDN W02020601

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6978848020457HT Basic UDI-DIDate2 Jun 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  • Withdrawn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 23 Oct 2026

Model / Reference
SA1, A00500000EN0
Primary DI / UDI-DI
06978848020457
Basic UDI-DI
6978848020457HT
EMDN Code
W02020601 Rapid test cell count instruments
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000047425
Authorised representative
GRZAN GmbH DE-AR-000038821

Other devices from Seamaty Diagnostic Technology (Chengdu) Co., Ltd.

See all devices from Seamaty Diagnostic Technology (Chengdu) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing
  • Professional Testing
  • Companion Diagnostics
  • Surgical Instrument
  • New Device
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No

Sources (1)

  • EUDAMED 1038300d-117f-4282-bec7-758e15c214af 61 fields · synced 23 Oct 2026