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Certifications & Patents

THE ONE MEDICAL operates in line with medical device quality management and regulatory requirements. We hold the quality system certification, manufacturing and sales licenses and patent certificates issued by Taiwan's competent authorities.

Quality System & Business Licenses

ISO 13485 Certificate

ISO 13485:2016

Medical Device Quality Management System Certificate

TFDA QMS Extension Letter

TFDA QMS

QMS Extension Approval Letter

Medical Device Manufacturer License

Medical Device Manufacturer License

THE ONE MEDICAL Devices Technology Appliance Co., Ltd.

Medical Device Seller License

Medical Device Seller License

THE ONE MEDICAL Devices Technology Appliance Co., Ltd.

Medical Device Registrations

Medical Device Registrations 009812

License No. 009812 (Ministry of Health and Welfare, Class I Manufacturing)

Video Rigid Laryngoscope (Class I)

Medical Device Registrations 009816

License No. 009816 (Ministry of Health and Welfare, Class I Manufacturing)

Single-Use Video Laryngoscope Blade (Class I)

Medical Device Registrations 009887

License No. 009887 (Ministry of Health and Welfare, Class I Manufacturing)

Video Laryngoscope Stylet (Class I)

Patents

Patent Certificate M667207

Patent Certificate M667207

Taiwan (R.O.C.) Utility Model Patent

THE ONE MEDICAL

THE ONE MEDICAL Devices Technology Appliance Co., Ltd.

THE ONE MEDICAL

Tel: +886 07-8216880

Address: 3F, No. 1-31, Kuojian Rd., Qianzhen Dist., Kaohsiung City, Taiwan

Website: https://theone-medical.com

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© 2026 THE ONE MEDICAL Devices Technology Appliance Co., Ltd. All rights reserved.
THE ONE MEDICAL

The One Medical Devices Technology Appliance Co., Ltd.

THE ONE MEDICAL

Tel: +886-7-821-6880

Address: 3F., No. 1-31, Kuojian Rd., Qianzhen Dist., Kaohsiung City 806, Taiwan

Website: https://theone-medical.com

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© 2026 The One Medical Devices Technology Appliance Co., Ltd. All rights reserved.
人一醫療 THE ONE MEDICAL

人一醫療器材股份有限公司

THE ONE MEDICAL

電話:+886 07-8216880

地址:高雄市前鎮區擴建路1之31號3樓

網站:https://theone-medical.com

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© 2026 人一醫療器材股份有限公司 THE ONE MEDICAL. 版權所有

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