Honors, Qualifications and Authoritative Certifications
ISO 13485 Certificate No.: ZC24AMQ00001M
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ISO 13485, ISO 9001 & ISO 14001
Certified Manufacturing Plant
The company has obtained multiple certifications, including ISO 13485, ISO 9001, and ISO 14001, and holds several international product certifications.
Management System Certifications
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ISO 9001 Certifications
ROMSKE operates under a fully implemented ISO 9001 Quality Management System covering the entire production lifecycle — from raw material control and process planning to final inspection and delivery.
Through standardized procedures, continuous improvement, and strict internal audits, we ensure consistent product quality and stable performance for OEM and ODM customers worldwide.
Through standardized procedures, continuous improvement, and strict internal audits, we ensure consistent product quality and stable performance for OEM and ODM customers worldwide.
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ISO 14001 Certifications
Our production facilities are dual-certified for quality and environmental management. We implement a full-lifecycle quality control system (IQC-IPQC-FQC-OQC) while maintaining a sustainable manufacturing environment, ensuring consistent performance for our global OEM and ODM partners.
Material Safety & Environmental Compliance
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RoHS &REACH Compliance
All ROMSKE beauty devices are manufactured in strict compliance with RoHS directives. We ensure that all components and housing materials are free from hazardous substances such as lead, mercury, and cadmium, guaranteeing safe daily use for end consumers.
Product & Market-Oriented Certifications
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CE & UKCA Conformity
For products entering the European and UK markets, ROMSKE provides comprehensive support for CE and UKCA conformity. Our engineering team assists with technical files, EMC testing, and LVD safety declarations to ensure smooth market entry.
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FCC & FDA Support
For the North American market, we provide FCC certification for electronic compatibility and offer robust support for FDA 510(k) or Class I/II listings. With experience in optical safety and biocompatibility standards, we facilitate the entire regulatory compliance process for global OEM/ODM partners.
Additional Safety & Performance Testing
Optical Energy Stability:
Precise calibration for IPL, Laser, and RF energy output.
Biocompatibility Testing:
Ensuring all skin-contact materials (silicone, metal probes) pass cytotoxicity and irritation tests.
Battery & Charging Safety:
Rigorous testing for lithium battery stability (UN38.3) and NTC thermal protection.
Clinical Efficacy Verification:
Support for laboratory-based skin improvement data and safety observation.
Certified Systems. Proven Aesthetics. Your Trusted Partner.
With a foundation built on medical-grade standards and global compliance, Simeah delivers beauty technology solutions that meet the world’s most stringent expectations for quality, safety, and visible results.