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Enbio S

by Enbio Technology Sp. z o. o. EUDAMED

Active European Union

Ref Enbio S

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number5904165sterylizatoryE2 Basic UDI-DIDate24 Jul 2023RegisteredStatusActive
European UnionCE/MDR Number5904165sterylizatoryE2 Basic UDI-DIDate24 Jul 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Enbio S
Primary DI / UDI-DI
59041656640062
Basic UDI-DI
5904165sterylizatoryE2, B-59041656640062
EMDN Code
Z12011305 Small load autoclaves with a chamber smaller than 1 standard sterilisation unit
Device Class
Class IIa
Class IIb
Special Device Type
Software
-1192
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000024063

Other devices from Enbio Technology Sp Z O O

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