Possible 注意喚起 against サーマクール(Thermage)

サーマクール(Thermage) (医薬品医療機器等法)
医薬品医療機器等法Ministry of Health, Labour and WelfarePossible entity match16 February 2017
For developers: integration details

You do not need this for normal browsing. Use it when integrating this enforcement record into an internal tool or AI workflow.

/api/v1/enforcements?company=%E3%82%B5%E3%83%BC%E3%83%9E%E3%82%AF%E3%83%BC%E3%83%AB%EF%BC%88Thermage%EF%BC%89&limit=10

Action summary

Company
Original: サーマクール(Thermage)
Entity match
Possible entity match60/100Machine extracted
Company name extracted from the Japanese public disclosure
Governing law
医薬品医療機器等法
医薬品医療機器等法
Action type
注意喚起
注意喚起
Action date
16 February 2017
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

As a result of using the modified medical device chip, damage occurred due to breakage, causing health harm (burns).

Show original Japanese text

医療機器の改造チップが使用された結果、その破損により健康被害(やけど)が発生。

Compliance context

Context needed

This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.

Japanese regulatory disclosure under 医薬品医療機器等法.

Review the original Japanese source and determine relevance to your counterparty-risk workflow.

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
2026-04-25T00:14:04.029+00:00
Evidence checked
2026-04-25T00:14:04.029+00:00
Archive captured
2026-04-07T12:02:26.469+00:00
Show audit JSON
{
  "record": {
    "id": "425953c9-5a46-4fcc-8a60-9a1eb5e9b570",
    "url": "https://regbase.jp/en/enforcement/other-samakuruthermage-20170216",
    "company_name_original": "サーマクール(Thermage)",
    "company_name_registry": "サーマクール(Thermage)",
    "corporate_number": null,
    "law": {
      "ja": "医薬品医療機器等法",
      "en": "医薬品医療機器等法"
    },
    "action_type": {
      "ja": "注意喚起",
      "en": "注意喚起"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "possible",
    "confidence": 60,
    "method": "extracted_japanese_name",
    "method_label": "Company name extracted from the Japanese public disclosure",
    "notes": null
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "Context needed",
    "actionMeaning": "This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.",
    "practicalNote": "Review the original Japanese source and determine relevance to your counterparty-risk workflow.",
    "lawContext": "Japanese regulatory disclosure under 医薬品医療機器等法."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-samakuruthermage-20170216",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000152001.html",
    "archiveUrl": "https://kiroku.today/view/4f665bfc08okkm9h",
    "archiveCapturedAt": "2026-04-07T12:02:26.469+00:00",
    "extractedAt": "2026-04-25T00:14:04.029+00:00",
    "translatedAt": "2026-05-01T07:03:50.505+00:00",
    "evidenceCheckedAt": "2026-04-25T00:14:04.029+00:00",
    "generatedAt": "2026-06-26T08:05:46.399Z"
  },
  "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
サーマクール(Thermage) Japanese original
Japanese name
サーマクール(Thermage)
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.