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Verify RK019

by Albert Browne, Ltd.

Ref RK019Model Steam and EO Combination indicators

Verify RK019 is a device classified as Class I in the EU and Class II in the US made by Albert Browne, Ltd., registered in EUDAMED on 6 Aug 2026 (Basic UDI-DI 0724995LCVERFYSTMEORCUL), cleared under FDA 510(k) K061738 on 25 Aug 2006 and listed in FDA GUDID since 29 May 2020 (UDI-DI 10724995172234), active as of 24 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 24 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K061738

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995LCVERFYSTMEORCUL Basic UDI-DI 10724995172234UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10724995172234 UDI-DI Date29 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK061738 Date25 Aug 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0724995LCVERFYSTMEORCUL registered 6 Aug 2026 Active
  • FDA 510(k) K061738 decided 25 Aug 2006 Active
  • FDA GUDID UDI-DI 10724995172234 listed 29 May 2020 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) K061738
  2. Listed FDA GUDID 10724995172234
  3. Registered EUDAMED 0724995LCVERFYSTMEORCUL

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  • Withdrawn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
Verify
Generic name
Chemical/physical sterilization process indicator
Device name
Steam and EO Combination indicators
Model / Ref / Catalog
RK019, Steam and EO Combination indicators
Primary DI / UDI-DI
10724995172234
Basic UDI-DI
0724995LCVERFYSTMEORCUL
Unit of use DI
00724995172237
510(k) Number
FDA product code
JOJ
EMDN code
Z12011385 Cleaning, disinfection and sterilisation instruments - consumables
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
Ireland
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: Chemical/physical sterilization process indicator

Similar devices in this category

Other devices filed under CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - CONSUMABLES.

Other devices from Albert Browne, Ltd.

See all devices from Albert Browne, Ltd. →

Properties

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