Administrative Guidance against 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 (医薬品医療機器等法)
医薬品医療機器等法Ministry of Health, Labour and WelfareConfirmed entity match3 August 2020
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/api/v1/enforcements?corporate_number=9100001025944&limit=10

Action summary

Company
Original: 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 extracted
Normalized Japanese name matched to a company profile with Corporate Number
Matched 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

Machine-translated summary — verify against original

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-medium

Administrative 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

Original Ministry of Health, Labour and Welfare announcement (Japanese)Archived source snapshot
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.

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
See company profile →

About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.