FDA Registration Active 🇨🇳 China

JOYTECH HEALTHCARE CO.,LTD.

Reg #: 3013053058 · FEI: 3013053058 · Expires 2026
Products
8
Proprietary Names
138
Establishment Types
3
Classifications
8

Registration Details

Registration Name
JOYTECH HEALTHCARE CO.,LTD.
Registration Number
3013053058
FEI Number
3013053058
Status
Active
Expiry Year
2026
Initial Importer
No
Address
No.365, Wuzhou Road
City
Hangzhou Zhejiang
Country
CN

Regulatory Submissions

510(k) Number
K172989

Owner / Operator

Firm Name
JOYTECH HEALTHCARE CO. LTD.
Operator Number
10054061
Address
No.365, Wuzhou Road
City
Hangzhou
State
Zhejiang
Postal Code
311100
Country
CN
Correspondent
Yunhua Ren

Products

Device Name Product Code
Pump, Breast, Powered HGX
System, Measurement, Blood-Pressure, Non-Invasive DXN
Continuous Measurement Thermometer FLL
Pump, Breast, Non-Powered HGY
Thermometer, Clinical Mercury FLK
Oximeter, Wellness PGJ
Nebulizer (Direct Patient Interface) CAF
Clinical Electronic Thermometer SDV

Proprietary Names

Mya Joy Electric Breast Pump Volueth Arm-type Fully Automatic Digital Blood Pressure Monitor DBP-62A1B MEDLOT Electric Blood Pressure Monitor Arm-type Fully Automatic Digital Blood Pressure Monitor Easy@Home Digital Basal Thermometer (EBT-018) Wondfo ® Digital Thermometer Wondfo ® Digital Thermometer, DMT-4760 203403 - Thermometer, DMT-4176.CVS Digital Thermometer DMT-4161,DMT-3062,DMT-4362,DMT-4171,DMT-4372,DMT-3072,DMT-4176,DMT-4377,DMT-412p,DMT-433p,DMT-416p 203388 - Thermometer, DMT-4726.CVS Rctl Digital Thermometer DMT-4161p,DMT-4362p,DMT-4171p,DMT-4372p,DMT-4759,DMT-4760,DMT-4760p,DMT-4763,DMT-4763p,DMT-4765 Digital Thermometer DMT-4765p,DMT-4773,DMT-4773p,DMT-4775,DMT-4775p Digital Thermometer DMT-437p,DMT-4336p,DMT-4153p,DMT-4132p,DMT-4333p,DMT-4326p,DMT-418p,DMT-4318p,DMT-4119p,DMT-4320p Wondfo ® Digital Thermometer, DMT-3072 203412 - Thermometer, DMT-4377.CVS Infrared Thermometer Item # 11110 Bluestone Blood Pressure Monitor Maverick Blood Pressure Monitor healthsmart Select Series Upper Arm Blood Pressure Monitor Item: 04-645-001 MABIS Universal Arm Talking Blood Pressure Monitor Item: 04-650-001 Maynovia Blood Pressure Monitor DBP-1312 Maynovia Blood Pressure Monitor DBP-1333 Health Sense Upper Arm Blood Pressure Monitor healthsmart Premium Series Upper Arm Blood Pressure Monitor Item: 04-655-001 Talking Sense Blood Pressure Monitor Maynovia Blood Pressure Monitor DBP-1359 healthsmart Standard Series Upper Arm Blood Pressure Monitor Item: 04-635-001 healthsmart Talking Infrared Ear & Forehead Thermometer Item: 18-930-000 One Step® Infrared Thermometer DET-3017 Infrared Forehead ThermometerDET-3019c,DET-3019b,DET-3021,DET-1000,DET-3000,DET-3022,DET-3023,DET-3023b, Infrared Forehead Thermometer DET-3024,DET-3024b, Infrared Forehead ThermometerDET-3015b,DET-3017a,DET-3017,DET-3018a,DET-3018,DET-3018c,DET-3018b,DET-3019a,DET-3019, Infrared Forehead Thermometer DET-3010,DET-3010b,DET-3011,DET-3011b,DET-3012,DET-3012b,DET-3020,DET-3020b,DET-3015, Infrared Ear/Forehead Thermometer DET-2126,DET-2126b healthsmart Touchless Infrared Thermometer Item: 18-555-0000 ChoiceMMed Blood Pressure Monitor MDBP203 Heart Check Digital Wrist Blood Pressure Monitor MABIS Universal Wrist Talking Blood Pressure Monitor Item: 04-815-001 Maynovia Blood Pressure Monitor DBP-2116 healthsmart Premium Series Universal Wrist Blood Pressure Monitor Item: 04-820-001 MOBI Wrist Blood Pressure Monitor with Batteries CLEVER CHOICE BLOOD PRESSURE MONITOR SDI-1586W Maynovia Blood Pressure Monitor DBP-2261 Maynovia Blood Pressure Monitor DBP-2141 MOBI Health Blood Pressure Monitor DBP-21E8 Maynovia Blood Pressure Monitor DBP-2253 healthsmart Standard Series Universal Wrist Blood Pressure Monitor Item: 04-810-001 MABIS Wrist Blood Pressure Monitor Item: 04-615-001 Maynovia Blood Pressure Monitor DBP-2127 Maynovia Blood Pressure Monitor DBP-2242 Drive Blood Pressure Monitor CLEVER CHOICE BLOOD PRESSURE MONITOR SDI-1986A Maynovia Blood Pressure Monitor DBP-1383 Blood Pressure Monitor ChoiceMMed Blood Pressure Monitor BP11 BJ120105 Blood Pressure Monitor MT-30 SmartHeart Premium Talking Automatic Digital BP Monitor (01-521) Maynovia Blood Pressure Monitor DBP-1334 Blood Pressure Monitor MT-55 Blood Pressure Monitor MT-45 Blood Pressure Monitor MT-50 Maynovia Blood Pressure Monitor DBP-1332 Quality Choice Talking Upper Arm Blood Pressure Monitor 89-521 CLEVER CHOICE BLOOD PRESSURE MONITOR SDI-1786A Quality Choice CUFF CLEVER CHOICE BLOOD PRESSURE MONITOR SDI-1486A Maynovia Blood Pressure Monitor DBP-1231 Physio Logic Essentia+ BPM 106-930(Joytech innerBlood Pressure Monitor BP-1364) healthsmart Universal Blood Pressure Cuff Item: 04-245-000 CLEVER CHOICE BLOOD PRESSURE MONITOR SDI-1796A Maynovia Blood Pressure Monitor DBP-1351 Blood Pressure Monitor DBP-13C2 CLEVER CHOICE BLOOD PRESSURE MONITOR SDI-1886A Large Adult Replacement Cuff, Black Item: 04-240-006 16-1994CF-XL Replacement Cuff-XL Adult Size 16-1991 Arm Digital BPM-Standard Adult Size DBP-61E2 211-2112B R.P.M. PRO Blood Pressure Monitor Blood pressure monitor DBP-6186 16-1994CF Replacement Cuff-Standard Adult Size Blood pressure monitor BU 720 16-1993XL Arm Digital BPM XL Adult Size DBP-61E2 Volueth Arm-type Fully Automatic Digital Blood Pressure Monitor DBP -6186 Arm-type Fully Automatic Digital BloodPressure Monitor Blood pressure monitor DBP-6186 Plus MEDICHOICE TRTM001 Easy@Home Digital Thermometer(EMT-026) Digital Thermometer AMDT10 Digital Thermometer AMDT13 Arise Medical Digital thermometer DMT-437 Digital Thermometer AMDT15 Digital Medical thermometer DMT4132 Digital Thermometer AMDT12 Easy@Home Rectal Digital Thermometer EMT-027 MAYNOVIA Digital Thermometer Digital Thermometer DMT-455 Digital Thermometer DMT-101 Digital Thermometer AMDT11 Digital thermometer DMT-3033 Digital Thermometer DMT-411 DMT-106 Equate 30 Second Rigid Tip Digital Thermometer (47-354CA) MEDICHOICE 916815A Digital Thermometer DMT-2067,DMT-2068,DMT-2069,DMT-4770 MEDICHOICE 916824 Digital thermometer MEDICHOICE 916814A MEDICHOICE 916821 Instant Digital Thermometer, 30-second readout MH-412 MEDICHOICE 916823 Equate 30 Second Rigid Tip Digital Thermometer (47-354) MEDICHOICE 916822 MEDICHOICE 916812B MEDICHOICE 916820A Digital Thermometer CIN: 5427802 Model No: 73-311-9 LEADER 60-sec Digital Thermometer Display CVS Health Flexible Tip Rapid Read Thermometer 65-203422(972313) Sejoy Infrared Forehead Thermometer Easy@Home Smart Basal Thermometer, EBT-770 CVS Health Flexible Tip Easy Read Thermometer 65-203425(193592) CVS Health Rectal Thermometer 65-203431(659813) CVS Health Multi-Tip Thermometer 65-203433(834807) Hopkins Medical Products DIGITALTHERMOMETER #579410 CVS Health Infrared Non-Contact Bluetooth Thermometer 65-203428(6359910) 302-6110B Trackstar Infrared Thermometer Apex digital thermometer Infrared Ear/Forehead Thermometer DMT-106 DIGITAL THERMOMETER CVS Health Flexible Tip Thermometer 65-203432(834795) 210-6110B R.P.M. PRO Infrared Thermometer DMT 101 DIGITAL THERMOMETER DET-306 Infrared thermometer CVS Health Flexible Tip Thermometer 65-203427(391983) CVS Health Rigid Tip Thermometer 65-203421(155912) TTT801B (DMT-4333) DIGITAL THERMOMETER 210-6130B R.P.M. Pro Flexible Tip Thermometer Infrared Ear Thermometer DET-1013,DET-1013b,DET-1015,DET-1015b,DET-5000,DET-1025,DET-1025b,DET-1026,DET-1026b Digital Thermometer DMT-4735b DMT-4735b Digital Thermometer DMT-4760b,DMT-4770b

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device