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PhenoMATRIX

by Copan Wasp S.r.l.

Ref WLAB-PHENOMATRIX

PhenoMATRIX (WLAB-PHENOMATRIX) is a device classified as Class C in the EU and Class II in the US made by Copan Wasp S.r.l., cleared under FDA 510(k) K251511 on 22 Jan 2026, registered in EUDAMED on 31 Jul 2023 (Basic UDI-DI 805014821IP250CMDSWM02ZA) and listed in FDA GUDID since 13 Feb 2026 (UDI-DI 58059796360857), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251511

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number58059796360857 UDI-DI Date13 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK251511 Date22 Jan 2026DecidedStatusActive
European UnionCE/IVDR EUDAMED Number805014821IP250CMDSWM02ZA Basic UDI-DI 58059796360857UDI-DIDate31 Jul 2023RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K251511 decided 22 Jan 2026 Active
  • EUDAMED Basic UDI-DI 805014821IP250CMDSWM02ZA registered 31 Jul 2023 Active
  • FDA GUDID UDI-DI 58059796360857 listed 13 Feb 2026 Listed

Timeline

3 dated events

  1. Registered EUDAMED 805014821IP250CMDSWM02ZA
  2. Cleared FDA 510(k) K251511
  3. Listed FDA GUDID 58059796360857

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Histology/cytology/microbiology image-analysis interpretive software IVD
Model / Ref / Catalog
WLAB-PHENOMATRIX
Primary DI / UDI-DI
58059796360857
Basic UDI-DI
805014821IP250CMDSWM02ZA
510(k) Number
FDA product code
PPU, QQY
EMDN code
W02039092 Various microbiology instruments - IVD medical device software
GMDN term
Histology/cytology/microbiology image-analysis interpretive software IVD
Device class
Class C EUDAMED
Class II GUDID
Regulation number
866.2190
Special device type
Software
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class C
GUDID
Class II

Device class is stated on each registry's own scale: Class C in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
IT-MF-000012489

Similar devices in this category

Other devices filed under VARIOUS MICROBIOLOGY INSTRUMENTS.

Other devices from Copan Wasp S.r.l.

See all devices from Copan Wasp S.r.l. →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (23, all answered No)