Enforcement record

Administrative Guidance disclosure naming 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 (医療機器の自主回収に関する規制)

This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.

医療機器の自主回収に関する規制Ministry of Health, Labour and WelfareGovernment disclosure30 September 2019

Action type

Administrative Guidance

Law

医療機器の自主回収に関する規制

Authority

Ministry of Health, Labour and Welfare

Action date

30 September 2019

Current page: Enforcement record

This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.

Source verification

Public-source and preservation status

Publishing authority: Ministry of Health, Labour and Welfare
Official source URL: Recorded by RegBase
Entity match: Not confirmed; shown under the published name
Kiroku preservation: Completed archive verified; Captured: Jul 12, 2026, 04:13 PM JST

“Confirmed” means that RegBase matched this record to the cited public disclosure or entity under the stated checks. It does not verify the truth of the disclosure or guarantee the entity’s current status, creditworthiness, or any legal conclusion.

Open the official source links in the section below to review the original disclosure.

Action summary

Company: 株式会社サンメディカル技術研究所Japanese only
Original: 株式会社サンメディカル技術研究所
Governing law: 医療機器の自主回収に関する規制
医療機器の自主回収に関する規制
Action type: Administrative Guidance
行政指導
Action date: 30 September 2019
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省
Industry context: 医療機器

Violation

Machine-translated summary — verify against original

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).

Show original Japanese text

血液ポンプ（植込み型補助人工心臓EVAHEARTの部品）の出荷時期：平成25年３月１日から平成29年５月29日まで、出荷台数：23台（未使用：１台）

Compliance context

Low-medium

Administrative guidance or supervision was publicly disclosed by the authority.

Japanese regulatory disclosure under 医療機器の自主回収に関する規制.

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.

Open original sources and verification detailsOfficial URL, direct PDF, and Kiroku archive

Original Ministry of Health, Labour and Welfare source (Japanese)Open preserved source and evidence pack

Extracted at: 2026-04-25T00:18:22.19+00:00
Evidence checked: 2026-04-25T00:18:22.19+00:00
Archive captured: 2026-07-12T07:13:02.905683+00:00

Show audit JSON

{
  "record": {
    "id": "f3e04479-7502-40a1-a7d1-0973e4271640",
    "url": "https://regbase.jp/en/enforcement/other-sanmedeikaruji-shu-yan-jiu-suo-20190930",
    "company_name_original": "株式会社サンメディカル技術研究所",
    "company_name_registry": null,
    "corporate_number": null,
    "law": {
      "ja": "医療機器の自主回収に関する規制",
      "en": "医療機器の自主回収に関する規制"
    },
    "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": "unresolved",
    "confidence": 85,
    "method": "nta_strict_name_nationally_unique",
    "method_label": "nta_strict_name_nationally_unique",
    "notes": "NTA full-download lookup found a nationally unique exact registered-name candidate (株式会社サンメディカル技術研究所). No Corporate Number was present in the disclosure, so this remains a likely match."
  },
  "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 医療機器の自主回収に関する規制."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-sanmedeikaruji-shu-yan-jiu-suo-20190930",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_07026.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/d55d2fa923hgepz0",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_07026.html",
    "archiveCapturedAt": "2026-07-12T07:13:02.905683+00:00",
    "extractedAt": "2026-04-25T00:18:22.19+00:00",
    "translatedAt": "2026-05-01T07:07:09.103+00:00",
    "evidenceCheckedAt": "2026-04-25T00:18:22.19+00:00",
    "generatedAt": "2026-09-20T21:20:51.671Z"
  },
  "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)

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