Enforcement record
承認 disclosure naming アラガン・ジャパン株式会社
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
Action type
承認
Law
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
Authority
Ministry of Health, Labour and Welfare
Action date
8 October 2019
RegBase evidence report
Japanese public-record enforcement check
Saveable record of the published action, regulator source, source status, and review notes for internal compliance files.
- Report ID
- RB-EN-ENFORCEMENT-OTHER-ARAGANZIYAP-202607271729
- Generated at
- 28 July 2026 at 02:29
- Record URL
- https://regbase.jp/en/enforcement/other-araganziyapan-20191008
1. Review Summary
| Disclosure name | アラガン・ジャパン株式会社 | Corporate Number | Not stated in the disclosure |
|---|---|---|---|
| Enforcement record | 1 record | Other confirmed records for this company | Outside this report's scope |
| Action date | 8 October 2019 | Authority | Ministry of Health, Labour and Welfare |
| Law | Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices | Action type | 承認 |
| Source status | Preserved public-source archive recorded | ||
This report summarizes public Japanese government disclosure data held by RegBase. It is not a credit score, sanctions conclusion, legal opinion, or adverse-media determination. Confirm important decisions against the linked official Japanese source.
2. Published Information
| Published name | アラガン・ジャパン株式会社 |
|---|
3. Enforcement Record
| Target name in disclosure | アラガン・ジャパン株式会社 |
|---|---|
| Authority | Ministry of Health, Labour and Welfare (厚生労働省) |
| Law / action type | Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices / 承認 |
| Action / announcement date | Action: 8 October 2019 / Announcement: 9 April 2026 |
| English summary | This product is a skin expander used to facilitate the insertion of artificial breasts during breast reconstruction surgery by embedding it under the skin or pectoral muscle for a certain period to expand and stretch the skin and other tissues around the breast. A component with a smooth surface, 'Natrell 133S Tissue Expander,' has been added. The product is a gel-filled artificial breast used for restoring or shaping the breast during breast reconstruction or augmentation in adult women. To expand the product line of smooth-surfaced variants, the Inspira series has been added to the components. |
| Original Japanese text | 本品は、乳房再建術時に人工乳房の埋入を容易にするため、事前に乳房皮下又は大胸筋下に一定期間埋め込み、乳房周辺部の皮膚及びその他の組織を拡張・伸展させる皮膚拡張器である。表面をスムーズ加工した構成品「ナトレル133S ティッシュ・エキスパンダー」が追加された。本品は、乳房の形状を修復または形成するために、乳房再建術又は成人女性の乳房増大術に使用されるゲル充填人工乳房である。スムーズ加工の製品バリエーション拡充のため、構成品にInspira シリーズが追加された。 |
| Official source | https://www.mhlw.go.jp/stf/newpage_07152.html |
| Source archive | https://kiroku.today/a/d35c7d2bd0hgeodw |
| Extraction / evidence timestamps | Extracted: 25 April 2026 at 09:18 / Evidence checked: 25 April 2026 at 09:18 / Archive captured: 12 July 2026 at 16:11 |
4. Business Location and Permit Details
No additional structured business-location or permit fields are recorded for this disclosure.
5. Other Confirmed Records for This Company
This report covers the single government disclosure shown on this page.
Reviewer Notes
| Reviewer | Team / company | ||
|---|---|---|---|
| Review purpose | |||
| Additional notes | |||
- □ Official source URL or archived source was checked.
- □ Corporate Number, address, or other identifiers were reviewed to avoid confusing similarly named entities.
- □ This document is understood as a public-record evidence file, not a credit decision or legal opinion.
Current page: Enforcement record
This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.
Free report
Save the disclosure record naming アラガン・ジャパン株式会社
Includes the published name, regulator, governing law, source links, archive status, and reviewer note fields for internal due-diligence files.
Preserved evidence by Kiroku
Review the preserved source for アラガン・ジャパン株式会社
Open the preserved public source with its capture time, original artifact, available verification data, and downloadable evidence pack.
For developers: JSON integration details
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Action summary
- Company
- アラガン・ジャパン株式会社Japanese onlyOriginal: アラガン・ジャパン株式会社
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices医薬品医療機器等法
- Action type
- 承認承認
- Action date
- 8 October 2019
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
- Industry context
- 医療機器
Violation
This product is a skin expander used to facilitate the insertion of artificial breasts during breast reconstruction surgery by embedding it under the skin or pectoral muscle for a certain period to expand and stretch the skin and other tissues around the breast. A component with a smooth surface, 'Natrell 133S Tissue Expander,' has been added. The product is a gel-filled artificial breast used for restoring or shaping the breast during breast reconstruction or augmentation in adult women. To expand the product line of smooth-surfaced variants, the Inspira series has been added to the components.
Show original Japanese text
本品は、乳房再建術時に人工乳房の埋入を容易にするため、事前に乳房皮下又は大胸筋下に一定期間埋め込み、乳房周辺部の皮膚及びその他の組織を拡張・伸展させる皮膚拡張器である。表面をスムーズ加工した構成品「ナトレル133S ティッシュ・エキスパンダー」が追加された。本品は、乳房の形状を修復または形成するために、乳房再建術又は成人女性の乳房増大術に使用されるゲル充填人工乳房である。スムーズ加工の製品バリエーション拡充のため、構成品にInspira シリーズが追加された。
Compliance context
Context neededThis is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.
Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices.
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
- Extracted at
- 2026-04-25T00:18:14.197+00:00
- Evidence checked
- 2026-04-25T00:18:14.197+00:00
- Archive captured
- 2026-07-12T07:11:59.062648+00:00
Show audit JSON
{
"record": {
"id": "d0a4267d-c20d-4491-b02f-d710f7d6dbe1",
"url": "https://regbase.jp/en/enforcement/other-araganziyapan-20191008",
"company_name_original": "アラガン・ジャパン株式会社",
"company_name_registry": null,
"corporate_number": null,
"law": {
"ja": "医薬品医療機器等法",
"en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
},
"action_type": {
"ja": "承認",
"en": "承認"
},
"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 (アラガン・ジャパン株式会社). No Corporate Number was present in the disclosure, so this remains a likely match."
},
"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 Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices."
},
"evidence": {
"recordUrl": "https://regbase.jp/en/enforcement/other-araganziyapan-20191008",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_07152.html",
"officialDocumentUrl": null,
"archiveUrl": "https://kiroku.today/a/d35c7d2bd0hgeodw",
"archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_07152.html",
"archiveCapturedAt": "2026-07-12T07:11:59.062648+00:00",
"extractedAt": "2026-04-25T00:18:14.197+00:00",
"translatedAt": "2026-05-01T07:07:03.467+00:00",
"evidenceCheckedAt": "2026-04-25T00:18:14.197+00:00",
"generatedAt": "2026-07-27T17:29:21.900Z"
},
"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.