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Prolystica

by STERIS Corporation 39 variants

Ref 1C3281PEModel Prolystica 2X Concentrate Neutral Detergent

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0724995SLPRLY2XCTNLDT8C Basic UDI-DI 00724995002145UDI-DIDate2 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Prolystica 2X Concentrate Neutral Detergent
Model / Reference
Prolystica 2X Concentrate Neutral Detergent, 1C3281PE
Primary DI / UDI-DI
00724995002145
Basic UDI-DI
0724995SLPRLY2XCTNLDT8C
EMDN Code
D99 Disinfectants, antiseptics, sterilising agents and detergents for medical devices - other
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000017373
Authorised representative
STERIS Ireland Ltd IE-AR-000010065

Other devices from Steris Corporation

See all devices from Steris Corporation →

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