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Colibrì PRIMARY TUBE WITH WATER

by Copan Wasp S.r.l.

Ref WR090-01-0003

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number18050148217975 UDI-DI Date31 Jan 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number805014821IP210ATUBEM04VF Basic UDI-DI 18050148217975UDI-DIDate7 Feb 2022RegisteredStatusActive

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 22 Oct 2026.

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  • Withdrawn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
Colibrì PRIMARY TUBE WITH WATER EUDAMED
Colibrí™ Primary Tube with Water GUDID
Generic Name
Buffered isotonic saline reagent IVD
Device Name
Primary Tubes
Model / Ref / Catalog
WR090-01-0003
Primary DI / UDI-DI
18050148217975
Basic UDI-DI
805014821IP210ATUBEM04VF
FDA Product Code
QBN, QQV, LON
EMDN Code
W0203010185 Antibiotic susceptibility analysers - consumables
GMDN Term
Buffered isotonic saline reagent IVD
Device Class
Class A EUDAMED
Class II GUDID
Regulation Number
866.3378, 866.1645
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

Manufacturer details

EUDAMED SRN
IT-MF-000012489

Other devices from Copan Wasp S.r.l.

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

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No