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WASPLab Single Incubator

by Copan Wasp S.r.l. 2 variants

Ref W087-011

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDR, withdrawn

Ended

Withdrawn

Date not published (CE IVDR)

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number805014821IP040AAUTOM01UB Basic UDI-DI 58050148211438UDI-DIDate20 Dec 2021RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number58050148211438 UDI-DI Date27 Apr 2021ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/IVDR Withdrawn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

Specification

EUDAMED · GUDID

Generic Name
Microbial incubator/imaging system IVD
Device Name
WASPLab System
Model / Ref / Catalog
W087-011
Primary DI / UDI-DI
58050148211438
Basic UDI-DI
805014821IP040AAUTOM01UB
FDA Product Code
JQP, JTQ
EMDN Code
W02039099 Various microbiology instruments - other
GMDN Term
Microbial incubator/imaging system IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
862.2100, 866.2540
EU market of registration
Italy
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class I

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

  • Surgical Instrument
  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: 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
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No