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Why Can We Always Ensure Excellent Quality

Quality Control

Huamei adheres to strict international quality standards to ensure safety, reliability and performance across all our devices. Our production system is managed under ISO13485 medical quality management, and our equipment complies with key global regulations, including CE, IEC 60601 safety standards, and other certification requirements for international markets.

Certification

Shandong Huamei Technology Co., Ltd. Certifications
Standard: TUV Medical CE
Number: No. G1 096896 0002 Rev.03
Issue Date: 2019-12-10
Expiry Date: 2027-05-26
Scope/Range: Medical Diode Laser System,
Issued By: TUV
Shandong Huamei Technology Co., Ltd. Certifications
Standard: FDA
Number: 3016170453
Issue Date: 2019-09-16
Expiry Date: 2099-11-17
Scope/Range: PDT photodynamic therapy equipment Non-laser PDT systems Beauty system devices (e.g., PL100, PL200, PL300, JM series, OV serie
Issued By: U.S. Food and Drug Administration (FDA).
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