510(k) Report

FDA applicant

Eumed Biotechnology Co., Ltd.

Hsin Chu City, TW2 decisions2004–20071 recall

FDA records 2 decisions for Eumed Biotechnology Co., Ltd. (Hsin Chu City, TW) from 2004 to 2007: 2 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and CGA (Glucose Oxidase, Glucose). Its devices cite 2 predicates, 1 of them its own earlier devices. 1 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 chemistry panel, where it files most

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

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Eumed Biotechnology Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Eumed Biotechnology Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NBWSystem, Test, Blood Glucose, Over The Counter1decision
  • CGAGlucose Oxidase, Glucose1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K040678Eusure Blood Glucose Monitoring SystemEumed Biotechnology Co., Ltd. · 20041cites it

What has FDA decided for it lately?

  • K062892EukareEumed Biotechnology Co., Ltd. · 20071 recall
  • K040678Eusure Blood Glucose Monitoring SystemEumed Biotechnology Co., Ltd. · 2004

All 2 as Eumed Biotechnology Co., Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K062892Smiths Medical CADD-Sentry Pro Medication Safety Software - electronic pump protocol…Aug 14, 2007