JOYTECH HEALTHCARE CO., LTD.

FDA Device Registration & Listing · Hangzhou Zhejiang, CN · Registration 3030671608

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3030671608
FEI Number
3030671608
Entity Name
JOYTECH HEALTHCARE CO., LTD.
City/State/Country
Hangzhou Zhejiang, CN
Establishment Address
No.502, Shunda Road, Hangzhou Zhejiang 311100, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
JOYTECH HEALTHCARE CO. LTD. (Owner Number: 10054061)
Owner / Operator Contact Address
No.365, Wuzhou Road, Hangzhou, CN-ZJ 311100, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231303
PMA Number
N/A

All Registered Proprietary Names

Electric Breast Pump Electric Breast Pump(LD-302) ChoiceMMed Blood Pressure Monitor MDBP203 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 Bluestone Blood Pressure Monitor 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 MEDLOT Electric Blood Pressure Monitor 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 Arm-type Fully Automatic Digital Blood Pressure Monitor 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 Digital Basal Thermometer (EBT-018) 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 ChoiceMMed Blood Pressure Monitor MDBP203 Heart Check Digital Wrist Blood Pressure Monitor Infrared Thermometer Item # 11110 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 Digital Thermometer DMT-4735b DMT-4735b Digital Thermometer DMT-4760b,DMT-4770b 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 Talking Sense Blood Pressure Monitor 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 MEDLOT Electric Blood Pressure Monitor 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 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 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 Wellavie Wrist-type Fully Automatic Digital Blood Pressure Monitor DBP-8178 Easy@Home Automatic Digital Blood Pressure Monitor, EBP-073 MH-6192-A Automated Blood Pressure Unit Arm-type Fully Automatic Digital Blood Pressure Monitor DBP-6191 MH-6192-C Automated Blood Pressure Unit Arm-type Fully Automatic Digital Blood Pressure Monitor Volueth Arm-type Fully Automatic Digital Blood Pressure Monitor DBP-6175 Arm-type Fully Automatic Digital Blood Pressure Monitor DBP-6175 Wrist-type Fully Automatic Digital Blood Pressure Monitor Mya Joy Electric Breast Pump 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 MEDLOT Electric Blood Pressure Monitor

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2024-12-24
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-03-01
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2026-05-07
FLK Thermometer, Clinical Mercury General Hospital Class 2 880.2920 2017-12-25
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2017-12-25
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2017-09-25
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2017-11-23
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-07-28
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2020-08-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-06-30
PGJ Oximeter, Wellness Cardiovascular Class 2 870.2700 2024-12-05
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-03-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-01-22
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2021-04-29
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-07-29
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-09-25
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2018-10-29
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2022-10-25
SDV Clinical Electronic Thermometer General Hospital Class 2 880.2910 2025-07-03
HGY Pump, Breast, Non-Powered Obstetrics/Gynecology Class 1 884.5150 2017-02-07
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-01-06
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2017-12-24
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2018-08-23
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-01-30

Official Correspondent

Yunhua Ren

US Agent Details

EDMONDO N. ROARK Email: ce3@sejoy.com Phone: (513) 2847182

Related Public Records

Same Entity

JOYTECH HEALTHCARE CO. LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013053058 JOYTECH HEALTHCARE CO.,LTD. Hangzhou Zhejiang, CN
3024790242 RENS MEDCARE (CAMBODIA) CO.,LTD. Sihanouk Preah Sihanouk, KH

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K190465 Hygeia II Medical Group, Inc. Evolve Breast Pump 2019-10-18
K021739 Limerick, Inc. LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002 2003-01-10
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030671608. Last updated year: 2026. Please use registration number 3030671608 when referencing this establishment in official correspondence.
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