510(k) Report

FDA applicant

Neich Medical (Shenzhen) Company Limited

Shenzhen, CN3 decisions2002–20040 recalls

FDA records 3 decisions for Neich Medical (Shenzhen) Company Limited (Shenzhen, CN) from 2002 to 2004: 3 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and DYB (Introducer, Catheter). No recall is linked to its devices.

FDA’s records also spell it “Neich Medical(Shenzhen)Company, Ltd.”.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Neich Medical (Shenzhen) Company Limited’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Neich Medical (Shenzhen) Company Limited since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Neich Medical (Shenzhen) Company Limited by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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