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Our Certificates
Class II Medical Device Business Filing Certificate
- Certificate Number:20253303
- Scope:Class II Medical Devices
- Issued By:Guangzhou Municipal Administration for Market Regulation
Medical Device Registration Certificate
- Certificate Number:20252190474
- Scope:RIC Hearing Aids
- Issued By:Shanghai Municipal Administration for Market Regulation
China Medical Device Registration Certificate
- Certificate Number:20242190464
- Scope:For hearing compensation in patients with conductive hearing loss.
- Issued By:Hunan Provincial Medical Products Administration
Certificate of Quality Management System
- Certificate Number:04726Q00400R001
- Scope:GB/T 19001-2016/ISO 9001:2015
- Issued By:Beijing Hua Guang Certification Of Medical Devices Co., Ltd.
Certificate Of Quality Management System For Medical Devices
- Certificate Number:04726M00400R000
- Scope:GB/T 42061-2022/ISO 13485:2016
- Issued By:Beijing Hua GuangCertification Of MedicalDevices Co., Ltd.
Certificate of Quality Management System
- Certificate Number:04726Q00400R001
- Scope:GB/T19001-2016/IS09001:2015
- Issued By:Beijing Guoyixie Huaguang Certification Co., Ltd
Medical Device Quality Management System Certificate
- Certificate Number:04726M00400R000
- Scope:GB/T 42061-2022/ISO 13485:2016
- Issued By:Beijing Guoyixie Huaguang Certification Co., Ltd.
Medical Device Manufacturing License
- Certificate Number:20255969
- Scope:Class II – Medical Rehabilitation Devices (Category 19)
- Issued By:Guangdong Provincial Medical Products Administration
Medical Device Registration Certificate of the PRC
- Certificate Number:20252190229
- Scope:For fitting and compensating hearing loss in patients with air‑conduction hearing impairment.
- Issued By:Jiangsu Provincial Drug Administration
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