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Integron® IT12

by Terragene S.A.

Ref IT12

Integron® IT12 is a device classified as Class I in the EU and Class II in the US made by Terragene S.A., registered in EUDAMED on 5 Nov 2025 (Basic UDI-DI 779816467CI5L) and listed in FDA GUDID since 21 Mar 2022 (UDI-DI 07798164672319), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number779816467CI5L Basic UDI-DI 07798164672319UDI-DIDate5 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07798164672319 UDI-DI Date21 Mar 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 779816467CI5L registered 5 Nov 2025 Active
  • FDA GUDID UDI-DI 07798164672319 listed 21 Mar 2022 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID 07798164672319
  2. Registered EUDAMED 779816467CI5L

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  • Withdrawn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
Integron™ IT12 EUDAMED
Integron® GUDID
Generic name
Chemical/physical sterilization process indicator
Device name
Terragene® Cleaning, disinfection and sterilization indicators
Model / reference
IT12
Primary DI / UDI-DI
07798164672319
Basic UDI-DI
779816467CI5L
Direct marketing DI
07798164676881
FDA product code
JOJ
EMDN code
S9080 Devices for sterilisation (excluding cat. d - z) - accessories
GMDN term
Chemical/physical sterilization process indicator
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.2800
EU registration type
Standard device
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Related devices

Category: Chemical/physical sterilization process indicator

Other devices from Terragene S.A.

See all devices from Terragene S.A. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)