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Chemdye® BDA4/1

by Terragene S.A.

Ref BDA4/1

Chemdye® BDA4/1 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), cleared under FDA 510(k) K200272 on 30 Jun 2020 and listed in FDA GUDID since 21 Mar 2022 (UDI-DI 07798164677857), active as of 25 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 25 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K200272

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number779816467CI5L Basic UDI-DI 07798164677857UDI-DIDate5 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07798164677857 UDI-DI Date21 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK200272 Date30 Jun 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 779816467CI5L registered 5 Nov 2025 Active
  • FDA 510(k) K200272 decided 30 Jun 2020 Active
  • FDA GUDID UDI-DI 07798164677857 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

3 dated events

  1. Cleared FDA 510(k) K200272
  2. Listed FDA GUDID 07798164677857
  3. Registered EUDAMED 779816467CI5L

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  • Withdrawn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
Chemdye™ BDA4/1 EUDAMED
Chemdye® GUDID
Generic name
Chemical/physical sterilization process indicator
Device name
Terragene® Cleaning, disinfection and sterilization indicators
Model / reference
BDA4/1
Primary DI / UDI-DI
07798164677857
Basic UDI-DI
779816467CI5L
510(k) Number
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
Spain
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

Cleared under the same submission (K200272)

and 2 more cleared under K200272

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)