Skip to content

Prolystica 1C12T4WR

by Steris Corporation

Ref 1C12T4WRModel Prolystica Ultra Concentrate Alkaline Detergent

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995SLPRLYSUCALKDTJM Basic UDI-DI 00724995089610UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995089610 UDI-DI Date31 Mar 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Prolystica
Generic Name
Medical device cleaning agent
Model / Ref / Catalog
1C12T4WR, Prolystica Ultra Concentrate Alkaline Detergent
Primary DI / UDI-DI
00724995089610
Basic UDI-DI
0724995SLPRLYSUCALKDTJM
FDA Product Code
FLG
EMDN Code
D99 Disinfectants, antiseptics, sterilising agents and detergents for medical devices - other
GMDN Term
Medical device cleaning agent
Device Class
Class I
Regulation Number
880.6150
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medical device cleaning agent

Other devices from Steris Corporation

See all devices from Steris Corporation →

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No