FDA.reportPublic FDA data

JOYTECH HEALTHCARE CO., LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30306716083030671608JOYTECH HEALTHCARE CO., LTD.1N2026-01-01No.502, Shunda Road Hangzhou Zhejiang CN 311100

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3260541618717375K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)DXN2026-08-26
3260541732253059K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)DXN2026-08-13
3260541245089711K252685Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)DXN2026-02-13
3260541969544738K252501Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)DXN2026-04-28
3260541121768672K250548Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)DXN2025-06-26
3260542020090342K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)CAF2025-07-02
3260541336161212K241431Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)DXN2025-01-13
3260541763101462K241322Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)HGX2024-12-19
3260541502479651K231303Arm-type Fully Automatic Digital Blood Pressure MonitorDXN2024-01-26
3260541424399684K230566Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure MonitorDXN2023-08-25
3260541104232333K213189Wrist-type Fully Automatic Digital Blood Pressure MonitorDXN2022-03-01
3260541346717995K212115Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure MonitorDXN2022-01-05
3260541610160688K200649Arm-Type Fully Automatic Digital Blood Pressure MonitorDXN2020-08-03
3260541768877187K200599Digital ThermometerFLL2020-07-08
3260541405061270K190886Non-invasive blood pressure measurement systemsDXN2019-07-29
3260541405666366K190873Infrared Ear/Forehead ThermometerFLL2019-07-26
3260541246235441K183393Digital ThermometerFLL2019-11-18
3260541319613528K182629Digital ThermometerFLL2019-02-28
3260541368775725K181239Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerFLL2018-10-29
3260541542020348K181081Infrared Ear ThermometerFLL2018-10-02
3260541536139201K173024Non-invasive blood pressure measurement systemsDXN2018-08-22
3260541610381239K172989Electric Breast PumpHGX2017-12-20
3260541283257286K170666The Wrist-Type Fully Automatic Digital Blood Pressure MonitorsDXN2017-11-22
3260541909544875K163518Digital ThermometerFLL2017-09-19
3260541733046792K112289DISPOSABLE THERMOMETER COVERS AND SHEATHSFLL2011-12-16
3260541012899848
3260541132762775
3260541548374894
3260541578877356
3260541763642572
3260541869308123
3260541911639618

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXN152026-08-26
FLL82020-07-08
HGX22024-12-19
CAF12025-07-02

PMN#