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Colibrí™ W090

by Copan Wasp Srl

Ref W090

Colibrí™ W090 is a device classified as Class A in the EU and Class II in the US made by Copan Wasp Srl, registered in EUDAMED on 21 Dec 2021 (Basic UDI-DI 805014821IP080AAUTOM01XX) and listed in FDA GUDID since 15 Nov 2022 (UDI-DI 58050148218208), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number58050148218208 UDI-DI Date15 Nov 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number805014821IP080AAUTOM01XX Basic UDI-DI 58050148218208UDI-DIDate21 Dec 2021RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805014821IP080AAUTOM01XX registered 21 Dec 2021 Active
  • FDA GUDID UDI-DI 58050148218208 listed 15 Nov 2022 Listed

Timeline

2 dated events

  1. Registered EUDAMED 805014821IP080AAUTOM01XX
  2. Listed FDA GUDID 58050148218208

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Colibrí EUDAMED
Colibrí™ GUDID
Generic name
Microbial specimen inoculation/streaking/colony-picking instrument IVD
Device name
Colibrí System
Model / Ref / Catalog
W090
Primary DI / UDI-DI
58050148218208
Basic UDI-DI
805014821IP080AAUTOM01XX
FDA product code
LON, QQV, QBN
EMDN code
W02030199 Antibiotic susceptibility analysers - other
GMDN term
Microbial specimen inoculation/streaking/colony-picking instrument IVD
Device class
Class A EUDAMED
Class II GUDID
Regulation number
866.1645, 866.3378
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 A
GUDID
Class II

Device class is stated on each registry's own scale: Class A 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: Microbial specimen inoculation/streaking/colony-picking instrument IVD

Similar devices in this category

Other devices filed under ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - OTHER.

Other devices from Copan Wasp Srl

  • Colibrí

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  • PhenoMATRIX

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  • URIVerse™ W095

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  • Colibri System

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See all devices from Copan Wasp Srl →

Properties

  • IVD instrument
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)