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Celerity PCC0078

by Albert Browne, Ltd.

Ref PCC078Model Celerity Vaporised Hydrogen Peroxide indicators

Celerity PCC0078 (PCC078) 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 0724995LCCELERITYHPCIST), cleared under FDA 510(k) K233187 on 27 Oct 2023 (1 earlier submission) and listed in FDA GUDID since 1 Nov 2019 (UDI-DI 10724995190665), 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) K233187

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995LCCELERITYHPCIST Basic UDI-DI 10724995190665UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK233187 Date27 Oct 2023DecidedStatusActive
United StatesGUDID listing GUDID Number10724995190665 UDI-DI Date1 Nov 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0724995LCCELERITYHPCIST registered 6 Aug 2026 Active
  • FDA 510(k) K233187 decided 27 Oct 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10724995190665 listed 1 Nov 2019 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

4 dated events

  1. Cleared FDA 510(k) K192020
  2. Listed FDA GUDID 10724995190665
  3. Cleared FDA 510(k) K233187
  4. Registered EUDAMED 0724995LCCELERITYHPCIST

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  • Withdrawn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
Celerity
Generic name
Chemical/physical sterilization process indicator
Device name
Celerity Vaporised Hydrogen Peroxide indicators
Model / Ref / Catalog
Celerity Vaporised Hydrogen Peroxide indicators, PCC078, PCC0078
Primary DI / UDI-DI
10724995190665
Basic UDI-DI
0724995LCCELERITYHPCIST
Unit of use DI
00724995190668
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Celerity Vaporised Hydrogen Peroxide indicators
PCC078
GUDID
PCC0078
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

Cleared under the same submission (K192020)

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)