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FW200

by Edif Instruments S.r.l. Italy EUDAMED

Ref ES00005-AV2Model Pulsar - Automated Immunochemistry Analyser

EMDN W0201010101,W0201020102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number805360894ES0000553 Basic UDI-DIDate24 May 2022RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Pulsar
Model / Reference
Pulsar - Automated Immunochemistry Analyser, ES00005-AV2
Primary DI / UDI-DI
80536089445990
Basic UDI-DI
805360894ES0000553
Direct Marketing DI
80536089445990
EMDN Code
W0201010101,W0201020102
Device Class
Class A

Manufacturer details

EUDAMED SRN
IT-MF-000009556

Other devices from Edif Instruments S.r.l.

See all devices from Edif Instruments S.r.l. →

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 (1)

  • EUDAMED c819691f-3f03-4d9c-811e-fe464af078c4 61 fields · synced 24 Oct 2026