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Bom

by Toruńskie Zakłady Materiałów Opatrunkowych Spółka Akcyjna Poland EUDAMED

Ref OM-191-FPPA-262

EMDN S01010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5900516AAEXXXXSB Basic UDI-DIDate29 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Medical Packaging
Model / Reference
OM-191-FPPA-262
Primary DI / UDI-DI
05900516335694
Basic UDI-DI
5900516AAEXXXXSB
EMDN Code
S01010101 Sterilisation pouches, flat, paper/plastic film
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000002200

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 61415616-bdb6-41ac-9867-0032814f6688 61 fields · synced 23 Oct 2026