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Na AFS2000A

by Guangzhou Labsim Biotech Co., Ltd United States EUDAMEDGUDID

Ref REF-TESTModel AFS800, L300, AFS2000A, AFS2600

Product code KHOEMDN W0299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number69701360302613M Basic UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06970136030100 UDI-DIDate20 May 2020ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 25 Oct 2026

Trade Name
Immunofluorescence Analyzer EUDAMED
Immunofluorescent Analyzer EUDAMED
Na GUDID
Generic Name
Fluorescent immunoassay analyser IVD, laboratory, semi-automated
Model / Reference
AFS2000A, AFS800, REF-TEST, L300, AFS2600
Primary DI / UDI-DI
06970136030100, 06970136030261, 06970136030667, 06970136030278
Basic UDI-DI
69701360302613M, 697013603002DR, 697013603010DQ, 697013603003DT
Direct Marketing DI
06970136030261
06970136030667
06970136030100
06970136030278
FDA Product Code
KHO
EMDN Code
W0299 IVD instruments - other
GMDN Term
Fluorescent immunoassay analyser IVD, laboratory, semi-automated
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
862.2560
Market of Registration
Spain
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class I

Related devices

Category: Fluorescent immunoassay analyser IVD, laboratory, semi-automated

Other devices from Guangzhou Labsim Biotech Co., Ltd

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Companion Diagnostics
  • Surgical Instrument
  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date
Other properties (17)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (5)

  • FDA UDI 64726bab-11bd-4f54-a10b-763a43c01921 34 fields · synced 25 Oct 2026
  • EUDAMED 06970136030261|69701360302613M 61 fields · synced 7 Oct 2026
  • EUDAMED 06970136030667|697013603002DR 61 fields · synced 16 Oct 2026
  • EUDAMED 06970136030100|697013603010DQ 61 fields · synced 25 Oct 2026
  • EUDAMED 06970136030278|697013603003DT 61 fields · synced 25 Oct 2026