FDA.reportPublic FDA data

TRULY INSTRUMENT CO., LTD.

Matched from indexed company URL: Truly Instrument Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30039805733003980573TRULY INSTRUMENT CO., LTD.1N2020-04-25NORTH OF THE DONG CHONG ROAD IND. AREA SHANWEI SHI Guangdong CN 516600

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
06939220800104TRULY Infrared Ear Thermometer - Infrared digital ear thermometer used for measuring body temperature.+866603360756Tanglinlin.sale@truly.com.cn

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
215531126642004K170545Automatic Wrist Bluetooth Blood Pressure MonitorDXN2017-11-21
215531758890965K161846Automatic Arm Bluetooth Blood Pressure MonitorDXN2016-10-24
215531437773839K113085TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITORDXN2012-01-12
215531444008781K113083TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDXN2012-01-19
215532030920791K091434TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63MDXN2009-09-04
215531170458787K091415TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702MDXN2009-09-04
215531226624987K090564TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370FLL2009-06-24
215531891270174K081852TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11DXN2008-12-12
215531567527136K014141DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11DXN2002-09-13
215531215842524
215531383373584
215531971188737

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXN82017-11-21
FLL12009-06-24

PMN#

GUDID#