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株式会社サンメディカル技術研究所

株式会社サンメディカル技術研究所· Corporate Number: 9100001025944

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Public Record Summary

Actions in last 3 years
0records
Actions in last year
0records
Latest action
about 5 years ago

3 Aug 2020

Total penalties
-

Enforcement and administrative action history

医薬品医療機器等法Administrative Guidance
Confirmed entity match

Regarding the 'Implantable Assist Artificial Heart EVAHEART' manufactured and sold by Sun Medical Technology Research Institute Co., Ltd., a Class I voluntary recall has been ongoing since September 2019. A death occurred on July 14, 2020, in a patient whose overall condition was poor and for whom the device could not be replaced.

3 Aug 2020Ministry of Health, Labour and Welfare
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Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesAdministrative Guidance
RepeatConfirmed entity match

Notification regarding response measures was made to related medical institutions by Sun Medical Technology Research Corporation

3 Aug 2020Ministry of Health, Labour and Welfare
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医療機器の自主回収に関する規制Administrative Guidance
Confirmed entity match

Blood pump (component of the implantable assist artificial heart EVAHEART) shipment period: from March 1, 2013 to May 29, 2017, number of units shipped: 23 (1 unused).

30 Sept 2019Ministry of Health, Labour and Welfare
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医薬品医療機器等法Administrative Guidance
Confirmed entity match

Product name: Double Cuff Tipless Cannula (part of the implantable artificial heart EVAHEART) Serial numbers: GU100-0077, GU100-0082, GU100-0084, GU100-0085, GU100-0087, GU100-0088, GU100-0090, GU100-0091 Shipment period: January 9, 2019 to March 28, 2019 Number of units shipped: 8

3 Apr 2019Ministry of Health, Labour and Welfare
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Language

日本語版を見る (Japanese)

Registry data

English name
株式会社サンメディカル技術研究所
Japanese name
株式会社サンメディカル技術研究所
Corporate Number
9100001025944
Registered address
長野県諏訪市大字四賀２９９０番地
Status
Active

Note: This company may not have detailed gBizINFO data, or RegBase has not completed enrichment yet. The public sources below may contain supplemental registry information.

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gBizINFO: fetched 25 Apr 2026

Data sources

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About this English name

No official English name source is recorded. The original Japanese name is shown.

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