Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024790242

FEI Number

3024790242

Entity Name

RENS MEDCARE (CAMBODIA) CO.,LTD.

City/State/Country

Sihanouk Preah Sihanouk, KH

Establishment Address

B-06-02, Sihanoukville SEZ, Sihanouk Preah Sihanouk 180108, KH

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

Expiration Date (Year)

2026

510(k) Number

K173024

PMA Number

N/A

All Registered Proprietary Names

Volueth Arm-type Fully Automatic Digital Blood Pressure Monitor DBP-62A1B MEDLOT Electric 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 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 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 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 Mya Joy Electric Breast Pump SEJOY Oral Irrigator 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 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
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	2017-09-25
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
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2017-02-07
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2021-04-29
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	2022-01-06
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-03-01
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-10-29
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	2025-01-22
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2024-09-29
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2019-11-22
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-08-23

Official Correspondent

Yunhua Ren

US Agent Details

EDMONDO ROARK Email: jingc@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
3030671608	JOYTECH HEALTHCARE CO., LTD.	Hangzhou Zhejiang, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

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 3024790242. Last updated year: 2026. Please use registration number 3024790242 when referencing this establishment in official correspondence.