FDA applicant

Shenzhen Bioeasy Biotechnology Co., Ltd.

Shenzhen, CN5 decisions2018–20230 recalls

FDA records 5 decisions for Shenzhen Bioeasy Biotechnology Co., Ltd. (Shenzhen, CN) from 2018 to 2023: 5 510(k) clearances. Most are in product codes NFW (Test, Cannabinoid, Over The Counter) and NGL (Test, Opiates, Over The Counter). Its devices cite 5 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical toxicology panel, where it files most

How often FDA has decided Shenzhen Bioeasy Biotechnology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2018high 2 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Shenzhen Bioeasy Biotechnology Co., Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Shenzhen Bioeasy Biotechnology Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?