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