FDA.reportPublic FDA data

ANDESFIT LIMITED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30140749233014074923ANDESFIT LIMITED1N2020-04-25Unit 513 Lakeside 1, No.8 Science Park West Ave., Hong Kong Scie HKG Not Applicable HK 000000

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2200831821820902K191657Bioland Blood Glucose Monitoring SystemNBW2020-03-20
2200831708454845K170965Fingertip Pulse OximeterDQA2017-11-03
2200831924792600K170954Portable ECG MonitorDPS2017-05-30
2200831846485402K170545Automatic Wrist Bluetooth Blood Pressure MonitorDXN2017-11-21
2200832019924407K170281MSA100BT Peak Flow MeterBZH2017-10-06
2200831589503128K161846Automatic Arm Bluetooth Blood Pressure MonitorDXN2016-10-24
2200831685560503K141362PULSE OXIMETER CMS50EWDQA2015-04-23
2200831364877894K140594BODY FAT ANALYZER AND SCALEMNW2014-05-30
2200831522854322K113077BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEMNBW2012-08-03
2200831587799917K090564TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370FLL2009-06-24

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW22020-03-20
DXN22017-11-21
DQA22017-11-03
BZH12017-10-06
DPS12017-05-30
MNW12014-05-30
FLL12009-06-24

GUDID#