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POCT Electrolyte Analyzer

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

Ref A00811000EN0Model SE1 EMDN W0201040201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6978848020365HM Basic UDI-DIDate9 Feb 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  • Withdrawn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 22 Oct 2026

Model / Reference
SE1, A00811000EN0
Primary DI / UDI-DI
06978848020365, 06975347780141
Basic UDI-DI
6978848020365HM, 6975347780141EX
EMDN Code
W0201040201, W0201040101
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000047425
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (2)

  • EUDAMED dbadb0b9-0687-40eb-ab16-3f369e2cc765 61 fields · synced 22 Oct 2026
  • EUDAMED 06975347780141|6975347780141EX 61 fields · synced 2 Aug 2026