Data / Medical devices / China / Wenzhou Renhua Instruments Co.,ltd
Wenzhou Renhua Instruments Co.,ltd: FDA-registered device maker in WENZHOU Zhejiang, China, 1 510(k) clearance
Wenzhou Renhua Instruments Co.,ltd is registered with the FDA (registration 3015220324) in WENZHOU Zhejiang, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 22, 2019. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015220324
- Address
- 3rd Floor, Building 2, No.1099 Kunbei Road, Lingkun Street Wenzhou Marine Economic Development Demonstration Zone, WENZHOU Zhejiang, China, 325026
- Owner or operator
- WENZHOU RENHUA INSTRUMENTS CO.,LTD (10059735)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 21, 2019
- Registered through
- 2026
- Brand names listed
- Blood Pressure Meter Model Max02 (Blue, Pink, green, gray, red, violet, yellow or Black cuff),, Blood Pressure Meter Model Max0201 (Blue, Pink, green, gray, red, violet, yellow or Black cuff),, Blood Pressure Meter Model Max0202((Blue, Pink, green, gray, red, violet, yellow or Black cuff), Blood Pressure Meter Model Max0203 (Blue, Pink, green, gray, red, violet, yellow or Black cuff),, Diagnostic pen light, Diagnostic pen light for SPHYGMOMANOMETER DIAGNOSIS KITS, Model MAX0206, NYLON CARRY BAG, NYLON CASE, Otoscope (RH7001) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Manufacturer | accessdata.fda.gov |
| Light, Examination, Medical, Battery Powered | KYT | 1 | Manufacturer | accessdata.fda.gov |
| Otoscope | ERA | 1 | Manufacturer | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| May 22, 2019 | K190902 | RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope | DXQ | Substantially Equivalent | Wenzhou Renhua Instruments Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stethoscope, Manual
- All makers of Blood Pressure Cuff
- All makers of Otoscope
- All makers of Light, Examination, Medical, Battery Powered
Updated May 22, 2019. 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.