Certificaciones
Estándar:
Class II Medical Device Business Filing Certificate
Número:
20253303
Alcance / gama:
Class II Medical Devices
Emitido por:
Guangzhou Municipal Administration for Market Regulation
Estándar:
Medical Device Registration Certificate
Número:
20252190474
Alcance / gama:
RIC Hearing Aids
Emitido por:
Shanghai Municipal Administration for Market Regulation
Estándar:
Certificate of Quality Management System
Número:
04726Q00400R001
Alcance / gama:
GB/T 19001-2016/ISO 9001:2015
Emitido por:
Beijing Hua Guang Certification Of Medical Devices Co., Ltd.
Estándar:
Certificate Of Quality Management System For Medical Devices
Número:
04726M00400R000
Alcance / gama:
GB/T 42061-2022/ISO 13485:2016
Emitido por:
Beijing Hua GuangCertification Of MedicalDevices Co., Ltd.
Estándar:
Certificate of Quality Management System
Número:
04726Q00400R001
Alcance / gama:
GB/T19001-2016/IS09001:2015
Emitido por:
Beijing Guoyixie Huaguang Certification Co., Ltd
Estándar:
Medical Device Quality Management System Certificate
Número:
04726M00400R000
Alcance / gama:
GB/T 42061-2022/ISO 13485:2016
Emitido por:
Beijing Guoyixie Huaguang Certification Co., Ltd.
Estándar:
Medical Device Manufacturing License
Número:
20255969
Alcance / gama:
Class II – Medical Rehabilitation Devices (Category 19)
Emitido por:
Guangdong Provincial Medical Products Administration
Estándar:
China Medical Device Registration Certificate
Número:
20242190464
Alcance / gama:
For hearing compensation in patients with conductive hearing loss.
Emitido por:
Hunan Provincial Medical Products Administration
Estándar:
Medical Device Registration Certificate of the PRC
Número:
20252190229
Alcance / gama:
For fitting and compensating hearing loss in patients with air‑conduction hearing impairment.
Emitido por:
Jiangsu Provincial Drug Administration
Perfil de la compañía
Hearing Earth (Guangzhou) Technology Co., Ltd.
Persona de contacto: MrsNora Hu