Enforcement record
指定 disclosure naming 株式会社ヘリオス
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
Action type
指定
Law
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
Authority
Ministry of Health, Labour and Welfare
Action date
28 February 2017
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-YAKKIHO-HERIOSU-2-202608041527
- Generated at
- 5 August 2026 at 00:27
- Record URL
- https://regbase.jp/en/enforcement/yakkiho-heriosu-20170228
1. Review Summary
| Disclosure name | 株式会社ヘリオス | Corporate Number | Not stated in the disclosure |
|---|---|---|---|
| Enforcement record | 1 record | Other confirmed records for this company | Outside this report's scope |
| Action date | 28 February 2017 | Authority | Ministry of Health, Labour and Welfare |
| Law | Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices | Action type | 指定 |
| 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 | 株式会社ヘリオス |
|---|
3. Enforcement Record
| Target name in disclosure | 株式会社ヘリオス |
|---|---|
| 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 / 指定 |
| Action / announcement date | Action: 28 February 2017 / Announcement: 2 May 2026 |
| English summary | On February 28, 2017, the Ministry of Health, Labour and Welfare designated a stem cell product derived from donor bone marrow, which is intended for the treatment of acute ischemic stroke within 18-36 hours of onset. The product consists of adult adherent stem cells used for medical purposes. The company involved is Helios Corporation. The product was classified as a regulated medical stem cell product under the Pharmaceutical and Medical Device Act. |
| Original Japanese text | 急性期(発症後18~36時間)の脳梗塞の治療を目的とした、ドナーの骨髄から採取して増殖させた成人接着性幹細胞に由来する幹細胞製品。 |
| Official source | https://www.mhlw.go.jp/stf/houdou/0000153128.html |
| Source archive | https://kiroku.today/a/60d0baf7afoak2ny |
| Extraction / evidence timestamps | Extracted: 2 May 2026 at 21:01 / Evidence checked: 2 May 2026 at 21:01 / Archive captured: 2 May 2026 at 21:01 |
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 株式会社ヘリオス
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Preserved evidence by Kiroku
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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
- 株式会社ヘリオスJapanese onlyOriginal: 株式会社ヘリオス
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices薬機法
- Action type
- 指定指定
- Action date
- 28 February 2017
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
- Industry context
- 医療用幹細胞
Violation
On February 28, 2017, the Ministry of Health, Labour and Welfare designated a stem cell product derived from donor bone marrow, which is intended for the treatment of acute ischemic stroke within 18-36 hours of onset. The product consists of adult adherent stem cells used for medical purposes. The company involved is Helios Corporation. The product was classified as a regulated medical stem cell product under the Pharmaceutical and Medical Device Act.
Show original Japanese text
急性期(発症後18~36時間)の脳梗塞の治療を目的とした、ドナーの骨髄から採取して増殖させた成人接着性幹細胞に由来する幹細胞製品。
Compliance context
Context neededThis is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.
Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising.
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
- 2026-05-02T12:01:57.095+00:00
- Evidence checked
- 2026-05-02T12:01:57.095+00:00
- Archive captured
- 2026-05-02T12:01:57.351371+00:00
Show audit JSON
{
"record": {
"id": "b230971f-1bba-4142-9cc1-21cbae664e61",
"url": "https://regbase.jp/en/enforcement/yakkiho-heriosu-20170228",
"company_name_original": "株式会社ヘリオス",
"company_name_registry": null,
"corporate_number": null,
"law": {
"ja": "薬機法",
"en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
},
"action_type": {
"ja": "指定",
"en": "指定"
},
"authority": {
"ja": "厚生労働省",
"en": "Ministry of Health, Labour and Welfare"
}
},
"entity_match": {
"status": "unresolved",
"confidence": 60,
"method": "extracted_japanese_name",
"method_label": "Company name extracted from the Japanese public disclosure",
"notes": "The linked company profile has not been verified under the current identity policy."
},
"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": "Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising."
},
"evidence": {
"recordUrl": "https://regbase.jp/en/enforcement/yakkiho-heriosu-20170228",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
"officialDocumentUrl": null,
"archiveUrl": "https://kiroku.today/a/60d0baf7afoak2ny",
"archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
"archiveCapturedAt": "2026-05-02T12:01:57.351371+00:00",
"extractedAt": "2026-05-02T12:01:57.095+00:00",
"translatedAt": "2026-07-06T07:52:00.859+00:00",
"evidenceCheckedAt": "2026-05-02T12:01:57.095+00:00",
"generatedAt": "2026-08-04T15:27:18.327Z"
},
"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.