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Celerity LCC015

by Albert Browne, Ltd.

Ref LCC015Model Peracetic Acid liquid chemical sterilant indicators

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) K243475

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995LCVERFYPERACIDK4 Basic UDI-DI 10724995229549UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK243475 Date4 Dec 2024DecidedStatusActive
United StatesGUDID listing GUDID Number10724995229549 UDI-DI Date22 Apr 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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
Medical device disinfection solution test strip
Device name
Peracetic Acid liquid chemical sterilant indicators
Model / Ref / Catalog
LCC015, Peracetic Acid liquid chemical sterilant indicators
Primary DI / UDI-DI
10724995229549
Basic UDI-DI
0724995LCVERFYPERACIDK4
Unit of use DI
00724995229542
510(k) Number
FDA product code
JOJ
EMDN code
Z12011385 Cleaning, disinfection and sterilisation instruments - consumables
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
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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Category: Medical device disinfection solution test strip

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Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date

Other properties (21)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Prescription use: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No