Manufacturer and brand owner in Wenzhou, Zhejiang, China. 7 device types, 6 products catalogued, 9 clearances.
Berpu Medical Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Micro Pipette, Needle, Dental and 5 other device types. 6 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2013.
Registration
FDA registration record for Berpu Medical Technology Co., Ltd. | Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004496829 |
| FEI number | 3004496829 |
| DUNS | 529239746 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
Address of Berpu Medical Technology Co., Ltd. | City | Wenzhou |
| Province | Zhejiang |
| Address | No.14 Xingji Road, Yongxing Street |
| Postal code | 325000 |
| Country | China |
Clearances
9 clearances name Berpu Medical Technology Co., Ltd. as applicant. 1 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.
From the Company
Published by the company on its own website, not by the FDA.
Information published by Berpu Medical Technology Co., Ltd. | Founded | 2000 |
| Factory area | 47,000 ㎡ |
| Main products | Insulin pen needles, Safety syringes, Hypodermic needles, Blood collection needles, Dental needles |
| Certifications | 130 domestic patents (38 invention), 14 foreign patents (13 invention), 11 Class III medical device registration, 3 Class II medical device registration |
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.