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Tissue Cassette Laser Printer

by Guangzhou Labsim Biotech Co., Ltd United States EUDAMED

Ref REF-TEST, REF-testModel TB286, TLB521A

EMDN W0299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697013603039EG 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 23 Oct 2026

Trade Name
Tissue Cassette Laser Printer
Laser Tissue Cassette
Model / Reference
TB286, REF-TEST, TLB521A
Primary DI / UDI-DI
06970136030391, 06970136030919
Basic UDI-DI
697013603039EG, 697013603091EJ
Direct Marketing DI
06970136030391
06970136030919
EMDN Code
W0299 IVD instruments - other
Device Class
Class A
Market of Registration
Germany
Italy

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 NoEUDAMEDYesEUDAMED
  • Surgical Instrument YesEUDAMEDNoEUDAMED
  • New Device
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No

Sources (2)

  • EUDAMED 0056d48b-f597-4908-bfb8-f2f435efd077 61 fields · synced 23 Oct 2026
  • EUDAMED 06970136030919|697013603091EJ 61 fields · synced 23 Oct 2026