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Prime|one

by Akzenta International SA EUDAMED

Active European Union

Ref STRAA26-AKZ-GR-C50

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42504766STAB Basic UDI-DIDate22 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Sterilization Reels and Bags
Model / Reference
STRAA26-AKZ-GR-C50
Primary DI / UDI-DI
04250476626013
Basic UDI-DI
42504766STAB
EMDN Code
S01020101 Flat sterilisation reels, paper/plastic film
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CH-MF-000036434
Authorised representative
IQX GmbH AT-AR-000016713

Other devices from Akzenta International SA

See all devices from Akzenta International SA →

Properties

Show properties
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