Data / Medical devices / Cambodia / Rens Medcare (cambodia) Co.,ltd.
Rens Medcare (cambodia) Co.,ltd.: FDA-registered device maker in Sihanouk Preah Sihanouk, Cambodia, 18 510(k) clearances
Rens Medcare (cambodia) Co.,ltd. is registered with the FDA (registration 3024790242) in Sihanouk Preah Sihanouk, Cambodia. It lists 7 device types. The FDA files 18 510(k) clearances under its listings, the newest dated August 26, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3024790242
- Address
- B-06-02, Sihanoukville SEZ, Sihanouk Preah Sihanouk, Cambodia, 180108
- Owner or operator
- JOYTECH HEALTHCARE CO. LTD. (10054061)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- February 7, 2017
- Registered through
- 2027
- Brand names listed
- 11-51D SmartHeart Deluxe Pulse Oximeter, 11-51DA SmartHeart Deluxe Pulse Oximeter, 16-1991 Arm Digital BPM-Standard Adult Size DBP-61E2, 16-1993XL Arm Digital BPM XL Adult Size DBP-61E2, 16-1994CF Replacement Cuff-Standard Adult Size, 16-1994CF-XL Replacement Cuff-XL Adult Size, 203388 - Thermometer, DMT-4726.CVS Rctl, 203403 - Thermometer, DMT-4176.CVS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Oximeter, Wellness | PGJ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pump, Breast, Non-Powered | HGY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 26, 2026 | K261394 | Arm-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) | DXN | Substantially Equivalent | JOYTECH Healthcare Co., Ltd. | accessdata.fda.gov |
| August 13, 2026 | K253425 | Arm-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) | DXN | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| April 28, 2026 | K252501 | Arm-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) | DXN | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| February 13, 2026 | K252685 | Arm-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) | DXN | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| June 26, 2025 | K250548 | Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) | DXN | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| January 13, 2025 | K241431 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193) | DXN | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| August 25, 2023 | K230566 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| March 1, 2022 | K213189 | Wrist-type Fully Automatic Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| January 5, 2022 | K212115 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| November 18, 2019 | K183393 | Digital Thermometer | FLL | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| July 29, 2019 | K190886 | Non-invasive blood pressure measurement systems | DXN | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| July 26, 2019 | K190873 | Infrared Ear/Forehead Thermometer | FLL | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| October 29, 2018 | K181239 | Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer | FLL | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| October 2, 2018 | K181081 | Infrared Ear Thermometer | FLL | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| August 22, 2018 | K173024 | Non-invasive blood pressure measurement systems | DXN | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| December 20, 2017 | K172989 | Electric Breast Pump | HGX | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| November 22, 2017 | K170666 | The Wrist-Type Fully Automatic Digital Blood Pressure Monitors | DXN | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| September 19, 2017 | K163518 | Digital Thermometer | FLL | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Clinical Electronic Thermometer
- All makers of Continuous Measurement Thermometer
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Pump, Breast, Powered
- All makers of Pump, Breast, Non-Powered
- All makers of Unit, Oral Irrigation
Updated August 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.