Komori
Leoclan (7681) · RiskRestated

Regulatory and Licensing Risks Related to Medical Device Sales and Other Activities

First written in FY2019. 15 of 16 entries say "Restated". Latest entry: FY2025.

16entries
7years
0from disclosures
Share on X
How it moved
ProgressHeldSoftenedWorseRestatedFY2019 – FY20252019: 12020: 120202021: 420212022: 220222023: 320232024: 320242025: 22025
Same theme, other companies
Risk of failing to obtain or renew construction and medical-device permitsA theme 2 companies write about · 2 as a headwind · 0 as a tailwind

0 other companies' latest entry also says "Restated".

Ridges = years it wrote progress, valleys = years it wrote worse. Most hopeful companies at the back. Drag to turn, scroll to zoom, right-drag to pan. On a phone, two fingers turn and pinch to zoom; one finger scrolls the page.
Full recordFilings, disclosures and news, newest first
  1. FY2025RestatedAnnual report

    「Because many of the products handled by the Group's companies are highly controlled medical devices, every business location handling such devices has obtained a license to sell and lease highly controlled medical devices under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.」

    The company continues to disclose the acquisition of licenses and permits for medical device sales, leasing and repair, pharmaceuticals, construction and other operations, and the risk that revocation of licenses could affect operating performance.
  2. FY2025-H1RestatedAnnual report

    「During the interim consolidated accounting period, there were no new occurrences of major risks that management recognizes could materially affect the financial position, operating results or cash flows of the consolidated companies among the matters concerning business conditions and financial matters described in this interim report, nor any material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」

    The company concludes that there were no material changes to the regulatory and licensing risks relating to medical device sales and other operations.
  3. FY2024RestatedAnnual report

    「Because many of the products handled by the Group's companies are highly controlled medical devices, every business location handling such devices has obtained a license to sell and lease highly controlled medical devices under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.」

    The company continues to disclose the acquisition of licenses and permits for medical device sales, leasing and repair, pharmaceuticals, construction and other operations, and the risk that revocation of licenses could affect operating performance.
  4. FY2024-Q2RestatedAnnual report

    「During the cumulative second quarter of the current consolidated fiscal year, there were no material changes in the occurrence of major risks that management recognizes could materially affect the financial position, operating performance or cash flows of the consolidated companies, among the matters concerning the business and accounting conditions described in the quarterly report, or in the business and other risks described in the annual securities report for the previous fiscal year.」

    The company concludes that there were no material changes to the regulatory and licensing risks relating to medical device sales and other operations.
  5. FY2024-Q1RestatedAnnual report

    「During the cumulative first quarter of the current consolidated fiscal year, there were no material changes in the occurrence of major risks that management recognizes could materially affect the financial position, operating performance or cash flows of the consolidated companies, among the matters concerning the business and accounting conditions described in the quarterly report, or in the business and other risks described in the annual securities report for the previous fiscal year.」

    The company concludes that there were no material changes to the regulatory and licensing risks relating to medical device sales and other operations.
  6. FY2023RestatedAnnual report

    「Because many of the products handled by the Group's companies are highly controlled medical devices, every business location handling such devices has obtained a license to sell and lease highly controlled medical devices under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.」

    The company continues to disclose the acquisition of licenses and permits for medical device sales, leasing and repair, pharmaceuticals, construction and other operations, and the risk of revocation due to violations of licensing requirements or relevant laws and regulations.
  7. FY2023-Q3RestatedAnnual report

    「During the cumulative third quarter of the current consolidated fiscal year, there were no material changes in the occurrence of major risks that management recognizes could materially affect the financial position, operating performance or cash flows of the consolidated companies, among the matters concerning the business and accounting conditions described in the quarterly report, or in the business and other risks described in the annual securities report for the previous fiscal year.」

    The company concludes that there were no material changes to the regulatory and licensing risks relating to medical device sales and other operations.
  8. FY2023-Q2RestatedAnnual report

    「During the cumulative second quarter of the current consolidated fiscal year, there were no material changes in the occurrence of major risks that management recognizes could materially affect the financial position, operating performance or cash flows of the consolidated companies, among the matters concerning the business and accounting conditions described in the quarterly report, or in the business and other risks described in the annual securities report for the previous fiscal year.」

    The company concludes that there were no material changes to the regulatory and licensing risks relating to medical device sales and other operations.
  9. FY2022-Q3RestatedAnnual report

    「During the cumulative third quarter of the current consolidated fiscal year, there were no material changes in the occurrence of major risks that management recognizes could materially affect the financial position, operating performance or cash flows of the consolidated companies, among the matters concerning the business and accounting conditions described in the quarterly report, or in the business and other risks described in the annual securities report for the previous fiscal year.」

    The company concludes that there were no material changes to the regulatory and licensing risks relating to medical device sales and other operations.
  10. FY2022-Q1RestatedAnnual report

    「During the cumulative first quarter of the current consolidated fiscal year, there were no material changes in the occurrence of major risks that management recognizes could materially affect the financial position, operating performance or cash flows of the consolidated companies, among the matters concerning the business and accounting conditions described in the quarterly report, or in the business and other risks described in the annual securities report for the previous fiscal year.」

    The company concludes that there were no material changes to the regulatory and licensing risks relating to medical device sales and other operations.
  11. FY2021RestatedAnnual report

    「Because many of the products handled by the Group's companies are highly controlled medical devices, every business location handling such devices has obtained a license to sell and lease highly controlled medical devices under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.」

    The company continues to disclose the acquisition of licenses and permits for medical device sales, leasing and repair, pharmaceuticals, construction and other operations, and the risk of revocation due to violations or failure to renew them.
  12. FY2021-Q3RestatedAnnual report

    「During the cumulative third quarter of the current consolidated fiscal year, there were no material changes in the occurrence of major risks that management recognizes could materially affect the financial position, operating performance or cash flows of the consolidated companies, among the matters concerning the business and accounting conditions described in the quarterly report, or in the business and other risks described in the annual securities report for the previous fiscal year.」

    The company concludes that there were no material changes to the regulatory and licensing risks relating to medical device sales and other operations.
  13. FY2021-Q2RestatedAnnual report

    「During the cumulative second quarter of the current consolidated fiscal year, there were no material changes in the occurrence of major risks that management recognizes could materially affect the financial position, operating performance or cash flows of the consolidated companies, among the matters concerning the business and accounting conditions described in the quarterly report, or in the business and other risks described in the annual securities report for the previous fiscal year.」

    The company concludes that there were no material changes to the regulatory and licensing risks relating to medical device sales and other operations.
  14. FY2021-Q1RestatedAnnual report

    「During the cumulative first quarter of the current consolidated fiscal year, there were no material changes in the occurrence of major risks that management recognizes could materially affect the financial position, operating performance or cash flows of the consolidated companies, among the matters concerning the business and accounting conditions described in the quarterly report, or in the business and other risks described in the annual securities report for the previous fiscal year.」

    The company concludes that there were no material changes to the regulatory and licensing risks relating to medical device sales and other operations.
  15. FY2020-Q1RestatedAnnual report

    「During the cumulative first quarter of the current consolidated fiscal year, there were no newly emerging business or other risks. There were also no material changes to the business and other risks described in the annual securities report for the previous fiscal year.」

    The company concludes that there were no material changes to the regulatory and licensing risks relating to medical device sales and other operations.
  16. FY2019First statedAnnual report

    「Because many of the products handled by the Group's companies are highly controlled medical devices, every business location handling such devices has obtained a license to sell and lease highly controlled medical devices under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.」

    The company lists licenses and permits for medical device sales, leasing and repair, pharmaceuticals, construction and other operations, and indicates that revocation due to violations of licensing requirements or relevant laws and regulations could materially affect operating performance and other factors.
Moved together

None of this company's other threads moved the same way in the same document twice or more.

When this could move next
No upcoming earnings preview for Leoclan yet.
News
No news is linked to this thread yet. When an article touches it, it will appear here by date.
Regulatory and Licensing Risks Related to Medical Device Sales and Other Activities | LEOCLAN Co.,Ltd. (7681) | Komori