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Bioteque America, Inc.

Model WC-400 · Bioteque Taiwan Ltd. · DI 00810142352406

KNA — Instrument, Manual, Specialized Obstetric-Gynecologic · Class II · 21 CFR 884.4530

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

23562019-01: 0 reports for this device; peer average 2.5/device2019-07: 0 reports for this device; peer average 3/device2020-02: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 6/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 3/device2025-05: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 2/device010702091203041103080102040503
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.5
2019-0703
2020-0202
2021-0903
2021-1203
2022-0301
2022-0402
2022-1102
2023-0301
2023-0806
2025-0102
2025-0202
2025-0403
2025-0501
2026-0302
This device (reports/month)Average device in KNA (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Bioteque Taiwan Ltd.

  • NAI 2020-01-23 Bioteque Taiwan Ltd. · 0 citations
  • NAI 2020-01-23 Bioteque Taiwan Ltd. · 0 citations
  • VAI 2016-12-08 Bioteque Taiwan Ltd. · 1 citations
  • VAI 2016-12-08 Bioteque Taiwan Ltd. · 1 citations
  • NAI 2014-04-03 Bioteque Taiwan Ltd. · 0 citations
  • NAI 2014-04-03 Bioteque Taiwan Ltd. · 0 citations