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25 EasyMax FTS Set EN-ES

Model EASY MAX · EPS BIO TECHNOLOGY CORP. · DI 00885017000270

NBW — System, Test, Blood Glucose, Over The Counter · Class II · 21 CFR 862.1345

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.

91827372019-01: 0 reports for this device; peer average 14.01/device2019-02: 0 reports for this device; peer average 19.34/device2019-03: 0 reports for this device; peer average 21.77/device2019-04: 0 reports for this device; peer average 28.26/device2019-05: 0 reports for this device; peer average 26.14/device2019-06: 0 reports for this device; peer average 24.19/device2019-07: 0 reports for this device; peer average 24.82/device2019-08: 0 reports for this device; peer average 22.58/device2019-09: 0 reports for this device; peer average 20.42/device2019-10: 0 reports for this device; peer average 22.67/device2019-11: 0 reports for this device; peer average 16.37/device2019-12: 0 reports for this device; peer average 19.89/device2020-01: 0 reports for this device; peer average 22.19/device2020-02: 0 reports for this device; peer average 18.44/device2020-03: 0 reports for this device; peer average 20.57/device2020-04: 0 reports for this device; peer average 17.63/device2020-05: 0 reports for this device; peer average 24.77/device2020-06: 0 reports for this device; peer average 30.27/device2020-07: 0 reports for this device; peer average 18.51/device2020-08: 0 reports for this device; peer average 12.33/device2020-09: 0 reports for this device; peer average 19.58/device2020-10: 0 reports for this device; peer average 12.45/device2020-11: 0 reports for this device; peer average 18.13/device2020-12: 0 reports for this device; peer average 18.98/device2021-01: 0 reports for this device; peer average 16.35/device2021-02: 0 reports for this device; peer average 17.07/device2021-03: 0 reports for this device; peer average 18.21/device2021-04: 0 reports for this device; peer average 19.62/device2021-05: 0 reports for this device; peer average 20/device2021-06: 0 reports for this device; peer average 19.7/device2021-07: 0 reports for this device; peer average 28.06/device2021-08: 0 reports for this device; peer average 17.13/device2021-09: 0 reports for this device; peer average 21.17/device2021-10: 0 reports for this device; peer average 19.14/device2021-11: 0 reports for this device; peer average 16.63/device2021-12: 0 reports for this device; peer average 23.6/device2022-01: 0 reports for this device; peer average 16.23/device2022-02: 0 reports for this device; peer average 15.33/device2022-03: 0 reports for this device; peer average 17.98/device2022-04: 0 reports for this device; peer average 16.62/device2022-05: 0 reports for this device; peer average 18.6/device2022-06: 0 reports for this device; peer average 14.8/device2022-07: 0 reports for this device; peer average 14.55/device2022-08: 0 reports for this device; peer average 8/device2022-09: 0 reports for this device; peer average 9.32/device2022-10: 0 reports for this device; peer average 8.08/device2022-11: 0 reports for this device; peer average 11.65/device2022-12: 0 reports for this device; peer average 7.24/device2023-01: 0 reports for this device; peer average 13.11/device2023-02: 0 reports for this device; peer average 9.6/device2023-03: 0 reports for this device; peer average 9.9/device2023-04: 0 reports for this device; peer average 7.78/device2023-05: 0 reports for this device; peer average 36.62/device2023-06: 0 reports for this device; peer average 23.03/device2023-07: 0 reports for this device; peer average 13.17/device2023-08: 0 reports for this device; peer average 11.24/device2023-09: 0 reports for this device; peer average 6.48/device2023-10: 0 reports for this device; peer average 6.48/device2023-11: 0 reports for this device; peer average 4.73/device2023-12: 0 reports for this device; peer average 4.39/device2024-01: 0 reports for this device; peer average 8.58/device2024-02: 0 reports for this device; peer average 2.73/device2024-03: 0 reports for this device; peer average 7.97/device2024-04: 0 reports for this device; peer average 4.02/device2024-05: 0 reports for this device; peer average 7.3/device2024-06: 0 reports for this device; peer average 5.13/device2024-07: 0 reports for this device; peer average 3.64/device2024-08: 0 reports for this device; peer average 3.3/device2024-09: 0 reports for this device; peer average 3.83/device2024-10: 0 reports for this device; peer average 4.44/device2024-11: 0 reports for this device; peer average 2.81/device2024-12: 0 reports for this device; peer average 5.57/device2025-01: 0 reports for this device; peer average 5.49/device2025-02: 0 reports for this device; peer average 2.66/device2025-03: 0 reports for this device; peer average 2.86/device2025-04: 0 reports for this device; peer average 3.69/device2025-05: 0 reports for this device; peer average 4.88/device2025-06: 0 reports for this device; peer average 3.09/device2025-07: 0 reports for this device; peer average 3.13/device2025-08: 0 reports for this device; peer average 4.73/device2025-09: 0 reports for this device; peer average 2.75/device2025-10: 0 reports for this device; peer average 3.59/device2025-11: 0 reports for this device; peer average 3.6/device2025-12: 0 reports for this device; peer average 2.64/device2026-01: 0 reports for this device; peer average 4.2/device2026-02: 0 reports for this device; peer average 2.35/device2026-03: 0 reports for this device; peer average 3.51/device2026-04: 0 reports for this device; peer average 3.03/device2026-05: 0 reports for this device; peer average 3.02/device2026-06: 0 reports for this device; peer average 4.17/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01014.01
2019-02019.34
2019-03021.77
2019-04028.26
2019-05026.14
2019-06024.19
2019-07024.82
2019-08022.58
2019-09020.42
2019-10022.67
2019-11016.37
2019-12019.89
2020-01022.19
2020-02018.44
2020-03020.57
2020-04017.63
2020-05024.77
2020-06030.27
2020-07018.51
2020-08012.33
2020-09019.58
2020-10012.45
2020-11018.13
2020-12018.98
2021-01016.35
2021-02017.07
2021-03018.21
2021-04019.62
2021-05020
2021-06019.7
2021-07028.06
2021-08017.13
2021-09021.17
2021-10019.14
2021-11016.63
2021-12023.6
2022-01016.23
2022-02015.33
2022-03017.98
2022-04016.62
2022-05018.6
2022-06014.8
2022-07014.55
2022-0808
2022-0909.32
2022-1008.08
2022-11011.65
2022-1207.24
2023-01013.11
2023-0209.6
2023-0309.9
2023-0407.78
2023-05036.62
2023-06023.03
2023-07013.17
2023-08011.24
2023-0906.48
2023-1006.48
2023-1104.73
2023-1204.39
2024-0108.58
2024-0202.73
2024-0307.97
2024-0404.02
2024-0507.3
2024-0605.13
2024-0703.64
2024-0803.3
2024-0903.83
2024-1004.44
2024-1102.81
2024-1205.57
2025-0105.49
2025-0202.66
2025-0302.86
2025-0403.69
2025-0504.88
2025-0603.09
2025-0703.13
2025-0804.73
2025-0902.75
2025-1003.59
2025-1103.6
2025-1202.64
2026-0104.2
2026-0202.35
2026-0303.51
2026-0403.03
2026-0503.02
2026-0604.17
This device (reports/month)Average device in NBW (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — EPS BIO TECHNOLOGY CORP.

  • Warning Letter 2012-09-12 EPS Bio Technology Corp.
  • Warning Letter 2012-09-12 EPS Bio Technology Corp.
  • VAI 2026-01-15 EPS Bio Technology Corp. · 3 citations
  • VAI 2026-01-15 EPS Bio Technology Corp. · 3 citations
  • VAI 2023-10-26 EPS Bio Technology Corp. · 0 citations
  • VAI 2023-10-26 EPS Bio Technology Corp. · 0 citations
  • VAI 2020-01-08 EPS Bio Technology Corp. · 0 citations
  • VAI 2020-01-08 EPS Bio Technology Corp. · 0 citations
  • VAI 2013-07-26 EPS Bio Technology Corp. · 0 citations
  • VAI 2013-07-26 EPS Bio Technology Corp. · 0 citations
  • OAI 2012-06-21 EPS Bio Technology Corp. · 0 citations
  • OAI 2012-06-21 EPS Bio Technology Corp. · 0 citations