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Cidex™ 20392

by Advanced Sterilization Products Services Inc.

Ref 20392

Cidex™ 20392 is a device classified as Class I in the EU and Class II in the US made by Advanced Sterilization Products Services Inc., registered in EUDAMED on 6 May 2026 (Basic UDI-DI 0705037A120000000000012L7), cleared under FDA 510(k) K081427 on 11 Jun 2008 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 20705037045553), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K081427

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705037A120000000000012L7 Basic UDI-DI 20705037045553UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20705037045553 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK081427 Date11 Jun 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0705037A120000000000012L7 registered 6 May 2026 Active
  • FDA 510(k) K081427 decided 11 Jun 2008 Active
  • FDA GUDID UDI-DI 20705037045553 listed 24 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K081427
  2. Listed FDA GUDID 20705037045553
  3. Registered EUDAMED 0705037A120000000000012L7

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
CIDEX™ OPA Solution Test Strips 60 Strips/Bottle EUDAMED
Cidex™ GUDID
Generic name
Medical device disinfection solution test strip
Model / Ref / Catalog
20392
Primary DI / UDI-DI
20705037045553
Basic UDI-DI
0705037A120000000000012L7
Unit of use DI
80705037045555
510(k) Number
FDA product code
JOJ
EMDN code
D99 Disinfectants, antiseptics, sterilising agents and detergents for medical devices - other
GMDN term
Medical device disinfection solution test strip
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.2800
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Ortho-phthalaldehyde (OPA) device disinfectant test strip

Cleared under the same submission (K081427)

Similar devices in this category

Other devices filed under DISINFECTANTS, ANTISEPTICS, STERILISING AGENTS AND DETERGENTS FOR MEDICAL DEVICES - OTHER.

Other devices from Advanced Sterilization Products, Inc.

See all devices from Advanced Sterilization Products, Inc. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)