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Automatic Fluorescence Immunoassay Analyzer

by Guangzhou Labsim Biotech Co., Ltd United States EUDAMED

Ref REF-TESTModel AFS3000, AFS330H

EMDN W0299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697013603059EN Basic UDI-DIDate27 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
Fluorescent Immunoassay Analyzer
Device Name
Automatic Fluorescence Immunoassay Analyzer
Model / Reference
AFS3000, REF-TEST, AFS330H
Primary DI / UDI-DI
06970136030599, 06970136030643
Basic UDI-DI
697013603059EN, 697013603064347
Direct Marketing DI
06970136030599
06970136030643
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
  • Near-Patient Testing YesEUDAMEDNoEUDAMED
  • Professional Testing
  • Companion Diagnostics
  • Surgical Instrument
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • New Device: No

Sources (2)

  • EUDAMED 7bac05bc-aa47-4767-a4ec-ab1e745cff59 61 fields · synced 22 Oct 2026
  • EUDAMED 06970136030643|697013603064347 61 fields · synced 10 Oct 2026