Data / Medical devices / China / Berpu Medical Technology Co., Ltd.
Berpu Medical Technology Co., Ltd.: FDA-registered device maker in WENZHOU Zhejiang, China, 8 510(k) clearances
Berpu Medical Technology Co., Ltd. is registered with the FDA (registration 3004496829) in WENZHOU Zhejiang, China. It lists 7 device types. The FDA files 8 510(k) clearances under its listings, the newest dated February 1, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004496829
- Address
- No.14 Xingji Road, Yongxing Street Longwan District, WENZHOU Zhejiang, China, 325000
- Owner or operator
- Berpu Medical Technology Co., Ltd. (9061974)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 7, 2013
- Registered through
- 2026
- Brand names listed
- Blunt Fill Needle, CONTAINER, SPECIMEN, STERILE, Insulin pen needle, Needle, hypodermic, single lumen, Sterile Dental Needles for Single Use, Sterile Irrigation Needle for Single Use, Syringe, piston, cobas sense venous pipettes
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Specimen, Sterile | FMH | 1 | Manufacturer | accessdata.fda.gov |
| Micro Pipette | JRC | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | 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 |
|---|---|---|---|---|---|---|
| February 1, 2024 | K232165 | Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles | FMI | Substantially Equivalent | Berpu Medical Technology Co., Ltd. | accessdata.fda.gov |
| November 3, 2022 | K221045 | Insulin Syringes without needle | FMF | Substantially Equivalent | Berpu Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 12, 2022 | K213811 | Sterile Hypodermic Syringes for Single Use | FMF | Substantially Equivalent | Berpu Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 29, 2022 | K212514 | Safety Pen Needle for Single Use, Insulin Pen Needles | FMI | Substantially Equivalent | Berpu Medical Technology Co., Ltd. | accessdata.fda.gov |
| March 12, 2019 | K181447 | Safety insulin needle for single use | FMI | Substantially Equivalent | Berpu Medical Technology Co., Ltd. | accessdata.fda.gov |
| August 9, 2018 | K180417 | Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use | MEG | Substantially Equivalent | Berpu Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 29, 2016 | K162180 | Disposable Insulin Syringe | FMF | Substantially Equivalent | Berpu Medical Technology Co., Ltd. | accessdata.fda.gov |
| February 25, 2014 | K133059 | INSULIN PEN NEEDLE | FMI | Substantially Equivalent | Wenzhou Beipu Science & Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Micro Pipette
- All makers of Container, Specimen, Sterile
- All makers of Needle, Dental
Updated February 1, 2024. 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.