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Immunofluorescence Analyzer

by Guangzhou Labsim Biotech Co., Ltd United States EUDAMED

Ref REF-TESTModel AFS800, L300

EMDN W0299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69701360302613M Basic UDI-DIDate6 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
AFS800, REF-TEST, L300
Primary DI / UDI-DI
06970136030261, 06970136030667
Basic UDI-DI
69701360302613M, 697013603002DR
Direct Marketing DI
06970136030261
06970136030667
EMDN Code
W0299 IVD instruments - other
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000002446
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Guangzhou Labsim Biotech Co., Ltd

Properties & raw data

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

Sources (2)

  • EUDAMED d4cf473b-6945-4392-acf3-76c5bc7ab96f 61 fields · synced 22 Oct 2026
  • EUDAMED 06970136030667|697013603002DR 61 fields · synced 16 Oct 2026