Compliance & Quality Certifications
CARESS No. 1 Originalᵀᴹ ensures the highest medical-grade safety standards. Access our full library of ISO certifications, FDA documentation, and sterilization reports.
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ISO 9001
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FDA REGISTERED
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CE COMPLIANT
Science
ASTM F138
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ISO Standard
ID: ISO-9001-15
ISO 9001:2015 Certification
Medical Device Quality Mgmt
Issued: Jan 2023
Expires: Jan 2026
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Regulatory
Reg: 3014529
FDA Establishment Registration
Compliance Certificate 2024
Status: Active
Renewal: Dec 2024
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Laboratory
Batch: EO-992
Ethylene Oxide Validation
Sterilization Efficacy Report
Tested: Mar 2023
Method: ISO 11135
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Materials
v4.2
Master Material Safety (MSDS)
Biocompatibility Assessment
Standard: ISO 10993
Updated: Nov 2023