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AUVON
Model DS-W · UAN HEALTHCARE LIMITED · DI 00850080988114
CGA — Glucose Oxidase, Glucose · Class II · 21 CFR 862.1345
NBW — System, Test, Blood Glucose, Over The Counter · Class II · 21 CFR 862.1345
QRK — Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature · Class II · 21 CFR 878.4850
QRL — Multiple Use Blood Lancet For Single Patient Use Only · Class II · 21 CFR 878.4850
UDILibrary device dossier · generated 2026-09-14 · 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)
2019-01
0
12.9
2019-02
0
17.85
2019-03
0
19.59
2019-04
0
26.01
2019-05
0
23.91
2019-06
0
21.7
2019-07
0
23.41
2019-08
0
20.36
2019-09
0
17.48
2019-10
0
18.86
2019-11
0
14.68
2019-12
0
17.28
2020-01
0
19.67
2020-02
0
16.11
2020-03
0
17.92
2020-04
0
16.02
2020-05
0
20.79
2020-06
0
26.64
2020-07
0
16.04
2020-08
0
11.09
2020-09
0
17.63
2020-10
0
11.11
2020-11
0
15.88
2020-12
0
16.39
2021-01
0
15.01
2021-02
0
15.47
2021-03
0
15.63
2021-04
0
15.61
2021-05
0
16
2021-06
0
16.87
2021-07
0
22.82
2021-08
0
15.16
2021-09
0
17.06
2021-10
0
15.57
2021-11
0
14.31
2021-12
0
19.02
2022-01
0
13.81
2022-02
0
12.69
2022-03
0
13.69
2022-04
0
13.36
2022-05
0
15
2022-06
0
12.08
2022-07
0
12.13
2022-08
0
7.47
2022-09
0
8.65
2022-10
0
7.5
2022-11
0
9.15
2022-12
0
6.64
2023-01
0
14.74
2023-02
0
7.94
2023-03
0
9.08
2023-04
0
7.11
2023-05
0
29.19
2023-06
0
19.88
2023-07
0
11.41
2023-08
0
9.86
2023-09
0
6.4
2023-10
0
5.71
2023-11
0
4.37
2023-12
0
4
2024-01
0
7.06
2024-02
0
2.83
2024-03
0
6.06
2024-04
0
4.07
2024-05
0
5.82
2024-06
0
4.49
2024-07
0
3.51
2024-08
0
3.29
2024-09
0
4.09
2024-10
0
4.19
2024-11
0
2.84
2024-12
0
4.64
2025-01
0
4.78
2025-02
0
2.77
2025-03
0
3.64
2025-04
0
4
2025-05
0
5.08
2025-06
0
3.11
2025-07
0
3.67
2025-08
0
4.19
2025-09
0
2.82
2025-10
0
3.47
2025-11
0
3.38
2025-12
0
2.64
2026-01
0
3.92
2026-02
0
2.38
2026-03
0
3.93
2026-04
0
3.47
2026-05
0
3.17
2026-06
0
4.07
This device (reports/month)Average device in CGA, NBW, QRK, QRL (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — UAN HEALTHCARE LIMITED