FDA.reportPublic FDA data

Curetis GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30144705793014470579Curetis GmbH1N2020-04-25Robert-Bosch-Strasse 4 Bodelshausen Baden-Wurttemberg DE 72411

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04260364750003Unyvero - Instrument to process 2 Unyvero Cartridges+1(619)452-3644support_us@curetis.com
04260364750010Unyvero - Instrument to pre-process up to 4 samples for Unyvero Cartridges+1(619)452-3644support_us@curetis.com
04260364750027Unyvero - User interface and instrument to control Unyvero Application workflow in combination with Unyvero L4 Lysator(s) and Unyvero A50 Analyzer(s)+1(619)452-3644support_us@curetis.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2180661100638478K191967Unyvero LRT BAL ApplicationQBH2019-12-20
2180661247374018DEN170047Curetis Unyvero LRT ApplicationQBH2018-04-03

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QBH22019-12-20

PMN#

GUDID#