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Bioteque Taiwan Ltd.
Model CUd10 · Bioteque Taiwan Ltd. · DI 04719894430409
HHW — Pessary, Vaginal · Class II · 21 CFR 884.3575
UDILibrary device dossier · generated 2026-09-07 · 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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-03
0
2
2019-08
0
1
2019-09
0
1
2019-11
0
1.33
2020-01
0
60.14
2020-02
0
1.75
2020-03
0
2.67
2020-04
0
1.5
2020-05
0
1.5
2020-06
0
1
2020-07
0
2.5
2020-08
0
1
2020-09
0
2.08
2020-10
0
1.33
2020-11
0
1.22
2020-12
0
1.25
2021-01
0
2
2021-02
0
1.13
2021-03
0
1
2021-06
0
1
2021-08
0
1
2021-09
0
1
2021-10
0
1.08
2021-11
0
1.17
2022-03
0
1
2022-04
0
3
2022-05
0
1
2022-06
0
1
2022-11
0
1.5
2023-01
0
1.17
2023-03
0
1
2023-05
0
2
2023-06
0
1
2023-08
0
1.5
2023-09
0
1
2023-11
0
1.43
2024-08
0
2
2024-12
0
1
2025-01
0
2
2025-03
0
3
2025-05
0
1.33
2025-08
0
1
2025-10
0
5
2025-11
0
1
2025-12
0
1
2026-05
0
2
This device (reports/month)Average device in HHW (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K092981 — cited as predicate by K132313, K231786
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Bioteque Taiwan Ltd.