JOYTECH HEALTHCARE CO.,LTD.

FDA Device Registration & Listing · Hangzhou Zhejiang, CN · Registration 3013053058

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
3013053058
FEI Number
3013053058
Entity Name
JOYTECH HEALTHCARE CO.,LTD.
City/State/Country
Hangzhou Zhejiang, CN
Establishment Address
No.365, Wuzhou 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
K252685
PMA Number
N/A

All Registered 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 MEDLOT Electric Blood Pressure Monitor 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

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 2017-12-24
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-08-28
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-11-22
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2022-10-25
HGY Pump, Breast, Non-Powered Obstetrics/Gynecology Class 1 884.5150 2017-02-07
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-07-28
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2023-05-03
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-09-25
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
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 2018-08-23
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-01-30
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2021-04-29
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2018-10-29
PGJ Oximeter, Wellness Cardiovascular Class 2 870.2700 2024-12-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2017-11-23
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2025-07-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2026-02-25

Official Correspondent

Yunhua Ren

US Agent Details

EDMONDO 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
3024790242 RENS MEDCARE (CAMBODIA) CO.,LTD. Sihanouk Preah Sihanouk, KH
3030671608 JOYTECH HEALTHCARE CO., LTD. Hangzhou Zhejiang, CN

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 3013053058. Last updated year: 2026. Please use registration number 3013053058 when referencing this establishment in official correspondence.
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