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EU authorised representative mandate Issuer CS Active, Latvia Reference CS/PK/EC-3102230LV Scope Class I medical devices listed in the document annex Issued 04 Oct 2025 Valid until 03 Oct 2026Immane Corporation documentation
Certifications and regulatory documents
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ISO 13485:2016 Issuer Dynamex Certification Services Reference DCS/1319-B Scope Manufacturer and exporter of surgical and dental instruments Issued 29 Oct 2025 Valid until 28 Oct 2026
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Class I CE compliance document Issuer Dynamex Certification Services Reference DCS/122900621-A Scope Reusable surgical and dental instruments described as Class I in the supplied document Issued 06 Dec 2025 Valid until 05 Dec 2026
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ISO 9001:2015 Issuer Dynamex Certification Services Reference DCS/1319-A Scope Manufacturer and exporter of surgical, dental, manicure/pedicure and veterinary instruments Issued 05 Dec 2025 Valid until 06 Dec 2026Historical US regulatory correspondence
FDA Import Alert 76-01
Our 15 August 2022 FDA letter concerns our Green List status under Import Alert 76-01. It does not indicate FDA approval or clearance of any product. Check the FDA's official list for current status and covered product categories.
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