Wenzhou Renhua Instruments Co., Ltd.
Manufacturer and brand owner in Wenzhou, Zhejiang, China. 4 device types, 6 products catalogued, 1 clearance.
Wenzhou Renhua Instruments Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Otoscope, Blood Pressure Cuff and 2 other device types. 6 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2019.
4device types registered with the FDA
6products catalogued under its own name
1510(k) clearance
Registration
| Registered name | WENZHOU RENHUA INSTRUMENTS CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015220324 |
| FEI number | 3015220324 |
| DUNS | 541055663 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 温州仁华仪表有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Wenzhou |
|---|---|
| Province | Zhejiang |
| Address | 3rd Floor, Building 2, No.1099 Kunbei Road, Lingkun Street |
| Postal code | 325026 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Blood Pressure Cuff | Class 2 | SPHYGMOMANOMETER DIAGNOSIS KITS, Model MAX0206,, 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), | 2019 | 50 |
| Light, Examination, Medical, Battery Powered | Class 1 | Diagnostic pen light for SPHYGMOMANOMETER DIAGNOSIS KITS, Model MAX0206, Diagnostic pen light | 2021 | 53 |
| Otoscope | Class 1 | Otoscope (RH7001) | 2019 | 43 |
| Stethoscope, Manual | Class 1 | SPHYGMOMANOMETER DIAGNOSIS KITS, Model MAX0206,, 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),, Nylon Carry BAG, Nylon Case and 14 more | 2019 | 64 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Blood Pressure Meter | DXQ | 4 |
| Single Head Stethoscope | LDE | 1 |
| Luxury Stethoscope | LDE | 1 |
| Dual Head Stethoscope | LDE | 1 |
| Rappaport Stethoscope | LDE | 1 |
| Stainless Steel Stethoscope | LDE | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K190902 | 2019-05-22 | DXQ | Traditional | This company |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.