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HistoPot 10% Neutral Buffered Formalin

by Serosep Limited Ireland EUDAMED

Ref 10-B-FOR-20L, S10-B-FOR-60ML, S10-B-FOR-1L, S10-B-FOR-60ML-ASZ, S10-B-FOR-125TRAY, S10-B-FOR-60TRAY, S10-B-FOR-180ML, S10-B-FOR-2.5L T/P, S10-B-FOR-250ML EMDN W05019099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0539151387HISTZN Basic UDI-DIDate26 May 2022RegisteredStatusActive

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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
10-B-FOR-20L, S10-B-FOR-60ML, S10-B-FOR-1L, S10-B-FOR-60ML-ASZ, S10-B-FOR-125TRAY, S10-B-FOR-60TRAY, S10-B-FOR-180ML, S10-B-FOR-2.5L T/P, S10-B-FOR-250ML
Primary DI / UDI-DI
05391513871504, 05391513871849, 05391513871962, 05391513872013, 05391513871955, 05391513872020, 05391513871863, 05391513871979, 05391513871870
Basic UDI-DI
0539151387HISTZN
Direct Marketing DI
05391513871504
05391513871849
05391513871962
05391513872013
05391513871955
05391513872020
05391513871863
05391513871979
05391513871870
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000020322

Other devices from Serosep, Ltd.

See all devices from Serosep, Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (9)

  • EUDAMED d2f4019b-65f9-4210-a644-2bab1103a965 61 fields · synced 25 Oct 2026
  • EUDAMED 05391513871849|0539151387HISTZN 61 fields · synced 18 May 2026
  • EUDAMED 05391513871962|0539151387HISTZN 61 fields · synced 18 May 2026
  • EUDAMED 05391513872013|0539151387HISTZN 61 fields · synced 18 May 2026
  • EUDAMED 05391513871955|0539151387HISTZN 61 fields · synced 18 May 2026
  • EUDAMED 05391513872020|0539151387HISTZN 61 fields · synced 18 May 2026
  • EUDAMED 05391513871863|0539151387HISTZN 61 fields · synced 18 May 2026
  • EUDAMED 05391513871979|0539151387HISTZN 61 fields · synced 18 May 2026
  • EUDAMED 05391513871870|0539151387HISTZN 61 fields · synced 18 May 2026