FDA.reportPublic FDA data

UNISENSOR USA, INC.

Matched from indexed company URL: UNISEN, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12267183003228575UNISENSOR USA, INC.1Y2020-04-25Pease International Tradeport 112 Corporate Drive, Unit 12 Portsmouth NH US 03801
97106393003126165UNISENSOR AG1N2020-04-25BAHNSTRASSE 12A ATTIKON Zurich CH CH-8544

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
07640172973684UniTip Catheter - K12504-00-1818-D+1(603)570-2675qm@unisensor.ch
07640172973691UniTip High Resolution Catheter - K1212A2-00-1821+1(603)570-2675qm@unisensor.ch
07640172973707UniTip High Resolution Catheter - K12959-L5-1801-D+1(603)570-2675qm@unisensor.ch
07640172973714UniTip High Resolution Catheter - K1213A2-L5-1822+1(603)570-2675qm@unisensor.ch

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
193651823947258K102801PHTIP DISPOSABLE ISFET CATHETERFFX2010-10-26
193661823947258K102801PHTIP DISPOSABLE ISFET CATHETERFFX2010-10-26
193651384006872K062222UNITIP HIGH RESOLUTION CATHETERFFX2007-03-15
193661384006872K062222UNITIP HIGH RESOLUTION CATHETERFFX2007-03-15
193651848764620K022023COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500KLA2003-01-07
193651364561352K003580UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETERFFX2001-07-31
193661364561352K003580UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETERFFX2001-07-31
193651192928011
193661192928011
193651500764625
193661500764625
193651800696074
193661800696074

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FFX62010-10-26
KLA12003-01-07

PMN#

GUDID#

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