Administrative Guidance against 株式会社サンメディカル技術研究所
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/api/v1/enforcements?corporate_number=9100001025944&limit=10Action summary
- Company
- 株式会社サンメディカル技術研究所Japanese originalOriginal: 株式会社サンメディカル技術研究所Corporate Number: 9100001025944
- Entity match
- Confirmed entity match95/100Machine extractedNormalized Japanese name matched to a company profile with Corporate NumberMatched by normalized Japanese company name to an enriched company profile with a Corporate Number.
- Governing law
- 医薬品医療機器等法医薬品医療機器等法
- Action type
- Administrative Guidance行政指導
- Action date
- 3 August 2020
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
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.
Show original Japanese text
株式会社サンメディカル技術研究所が製造販売する「植込み型補助人工心臓EVAHEART」については、令和元年9月より自主回収(クラスⅠ)を実施しているところですが、全身状態が悪く当該製品の交換ができなかった患者において、令和2年7月14日に死亡事例が発生した。
Compliance context
Low-mediumAdministrative guidance or supervision was publicly disclosed by the authority.
Japanese regulatory disclosure under 医薬品医療機器等法.
Use as a monitoring signal. Confirm details before treating it as a formal sanction.
This context is an operational aid for review workflows, not a credit opinion or legal conclusion.
Evidence pack
- Extracted at
- 2026-04-25T00:19:36.22+00:00
- Evidence checked
- 2026-04-25T00:19:36.22+00:00
- Archive captured
- 2026-04-09T12:01:35.434+00:00
Show audit JSON
{
"record": {
"id": "32dc5b5e-c461-4858-bae1-05db521254cb",
"url": "https://regbase.jp/en/enforcement/other-sanmedeikaruji-shu-yan-jiu-suo-20200803",
"company_name_original": "株式会社サンメディカル技術研究所",
"company_name_registry": "株式会社サンメディカル技術研究所",
"corporate_number": "9100001025944",
"law": {
"ja": "医薬品医療機器等法",
"en": "医薬品医療機器等法"
},
"action_type": {
"ja": "行政指導",
"en": "Administrative Guidance"
},
"authority": {
"ja": "厚生労働省",
"en": "Ministry of Health, Labour and Welfare"
}
},
"entity_match": {
"status": "confirmed",
"confidence": 95,
"method": "normalized_name_with_corporate_number",
"method_label": "Normalized Japanese name matched to a company profile with Corporate Number",
"notes": "Matched by normalized Japanese company name to an enriched company profile with a Corporate Number."
},
"review": {
"status": "unreviewed",
"label": "Machine extracted"
},
"compliance_context": {
"severity": "Low-medium",
"actionMeaning": "Administrative guidance or supervision was publicly disclosed by the authority.",
"practicalNote": "Use as a monitoring signal. Confirm details before treating it as a formal sanction.",
"lawContext": "Japanese regulatory disclosure under 医薬品医療機器等法."
},
"evidence": {
"recordUrl": "https://regbase.jp/en/enforcement/other-sanmedeikaruji-shu-yan-jiu-suo-20200803",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_12767.html",
"archiveUrl": "https://kiroku.today/view/284b8a2d66rff87o",
"archiveCapturedAt": "2026-04-09T12:01:35.434+00:00",
"extractedAt": "2026-04-25T00:19:36.22+00:00",
"translatedAt": "2026-05-01T07:08:08.671+00:00",
"evidenceCheckedAt": "2026-04-25T00:19:36.22+00:00",
"generatedAt": "2026-06-19T12:15:26.640Z"
},
"limitations": [
"RegBase aggregates public Japanese government disclosures and does not provide a credit opinion.",
"English summaries are provided for reference. The original Japanese source is authoritative.",
"Possible or unresolved entity matches should be manually verified before use in a decision."
]
}The original Japanese disclosure is the authoritative record. Use possible or unresolved matches only as leads for manual review.
Language
日本語版を見る (Japanese)Company info
- English name
- 株式会社サンメディカル技術研究所 Japanese original
- 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
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.