Wenzhou Dongfang Medical Instruments Co., Ltd.
Registered establishment in Wenzhou, Zhejiang, China. 10 device types.
Wenzhou Dongfang Medical Instruments Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Otoscope, Hammer, Surgical and 8 other device types. Its earliest product listing with the FDA dates from 2004.
Registration
| Registered name | WENZHOU DONGFANG MEDICAL INSTRUMENTS CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004784770 |
| FEI number | 3004784770 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 温州市东方医疗器械有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Wenzhou |
|---|---|
| Province | Zhejiang |
| Address | #143, Zhongxin Road, Wenzhou Industry Zone |
| Postal code | 325013 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Face Shield, Disposable Face Mask | 2008 | 439 |
| Blood Pressure Cuff | Class 2 | B.P. Monitor With Stethoscope, Blood Pressure Monitor, Blood Pressure Cuff | 2008 | 50 |
| Hammer, Surgical | Class 1 | Reflex Hammer | 2006 | 20 |
| Non-Surgical Gown | Class 1 | Isolation Gown | 2012 | 318 |
| Otoscope | Class 1 | Kindcare Otoscope, Penlight | 2007 | 43 |
| Respirator, Surgical | Class 2 | KN95 Mask, Medical Respirator | 2020 | 118 |
| Scissors, General, Surgical | Class 1 | Bandage Scissors | 2015 | 83 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Goggles, Snow Goggles, Sand Protection Goggles, Nursing Goggles, Medical Goggles, Safety Goggles and 1 more | 2020 | 384 |
| Stethoscope, Manual | Class 1 | Kindcare Stethoscope | 2004 | 64 |
| Tourniquet, Nonpneumatic | Class 1 | Injection PAD, Tourniquet ,nonpneumatic | 2007 | 124 |
Clearances
No clearance names Wenzhou Dongfang Medical Instruments Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K081951 | 2008-08-15 | DXQ | Traditional | Wenzhou Kindcare Import & Export Co., Ltd. |
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.