FDA.reportPublic FDA data

SENZIME AB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30164900243016490024SENZIME AB1N2026-01-01Verkstadsgatan 8 Uppsala SE 75323

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2384461986626041K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)KOI2026-05-22
2384461931962260K220530Tetragraph Neuromuscular Transmission MonitorKOI2022-08-17
2384461834062886K192595ExSpiron 2XiBZK2019-12-17
2384461105026115K190795Tetragraph Neuromuscular Transmission MonitorKOI2019-10-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KOI32026-05-22
BZK12019-12-17

PMN#