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TissueGuard™ Gel

by SLMP LLC d.b.a. StatLab Medical Products EUDAMED

Active European Union

Ref TG12

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0850049730EM001MT Basic UDI-DIDate24 Jul 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
TissueGuard™ Gel,
Model / Reference
TG12
Primary DI / UDI-DI
00850049730143
Basic UDI-DI
0850049730EM001MT
EMDN Code
W05030599 Devices for patology tests - other
Device Class
Class A
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
US-MF-000029059
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from SLMP LLC d.b.a. StatLab Medical Products

See all devices from SLMP LLC d.b.a. StatLab Medical Products →

Properties

  • Reagent

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No