Berpu Medical Technology Co., Ltd.
WENZHOU Zhejiang, CN
Berpu Medical Technology Co., Ltd. appears in FDA device records in WENZHOU Zhejiang, CN. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Berpu Medical Technology Co., Ltd. between 2016 and 2024. The busiest year on record is 2022, with 5. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2022 | 5 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | |
| K221045 | Insulin Syringes without needle | FMF | Substantially Equivalent | |
| K220061 | Safety Insulin Syringes | MEG | Substantially Equivalent | |
| K213158 | Syringe with permanently attached needle | FMF | Substantially Equivalent | |
| K213811 | Sterile Hypodermic Syringes for Single Use | FMF | Substantially Equivalent | |
| K212514 | Safety Pen Needle for Single Use, Insulin Pen Needles | FMI | Substantially Equivalent | |
| K181447 | Safety insulin needle for single use | FMI | Substantially Equivalent | |
| 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 | |
| K162180 | Disposable Insulin Syringe | FMF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004496829 | 3004496829 | Berpu Medical Technology Co., Ltd. | No.14 Xingji Road, Yongxing Street, WENZHOU Zhejiang 325000 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain