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Bionova® PCD225-C

by Terragene S.A.

Ref PCD225-C

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) K242453

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number779816467CI5L Basic UDI-DI 07798164677970UDI-DIDate5 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07798164677970 UDI-DI Date1 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK242453 Date12 Dec 2024DecidedStatusActive

Official records

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 24 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  • Withdrawn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
Bionova™ PCD225-C EUDAMED
Bionova® GUDID
Generic name
Biological sterilization indicator
Device name
Terragene® Cleaning, disinfection and sterilization indicators
Model / reference
PCD225-C
Primary DI / UDI-DI
07798164677970
Basic UDI-DI
779816467CI5L
Direct marketing DI
07798164677970
510(k) Number
FDA product code
FRC
EMDN code
S9080 Devices for sterilisation (excluding cat. d - z) - accessories
GMDN term
Biological sterilization 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: Biological sterilization indicator

Cleared under the same submission (K242453)

Other devices from Terragene S.A.

See all devices from Terragene S.A. →

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