Data / Medical devices / Otoscope / China

FDA-registered makers of Otoscope in China: 41 establishments

Name: FDA-registered makers of Otoscope in China
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

41 establishments in China are registered with the FDA to make Otoscope (product code ERA). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device: Otoscope
Product code: ERA
Country: China

Makers of Otoscope in China

Maker	Location	Role	Source
Anqing Changfan Medical Instrument Co., Ltd	Anqing Anhui, China	Exporter to the US, Manufacturer	api.fda.gov
Aoj Health Technology Co., Ltd.	Shenzhen Guangdong, China	Contract manufacturer, Manufacturer	api.fda.gov
Ari Medical Technology Co., Ltd.	Hefei Anhui, China	Manufacturer	api.fda.gov
Anhui Shiyin Photoelectric Instrument Co., Ltd.	Suzhou Anhui, China	Manufacturer, Specification developer	api.fda.gov
Dongguan Anhuan Electronic Co., Limited	Dongguan Guangdong, China	Manufacturer	api.fda.gov
Dongguan Hems Electronic Technology Co.,ltd.	Dongguan Guangdong, China	Manufacturer	api.fda.gov
Dongguan Yipincheng Technology Co., Ltd.	Dongguan Guangdong, China	Manufacturer	api.fda.gov
Essentia Industries Ltd.	Dong Guan Guangdong, China	Exporter to the US, Manufacturer, Repackager or relabeler	api.fda.gov
Fastsound Acoustic Technology (hangzhou) Co., Ltd.	Hangzhou Zhejiang, China	Manufacturer	api.fda.gov
Fenghua Tealmed Emergency Products Co.,ltd.	Ningbo Zhejiang, China	Manufacturer	api.fda.gov
Foshan Any Home Care Medical Technology Co.,ltd.	Foshan Guangdong, China	Manufacturer	api.fda.gov
Hangzhou Endo Medical Instrument Co.,ltd	hangzhou Zhejiang, China	Manufacturer	api.fda.gov
Heifeng Zhizao(shenzhen)technology Co.,ltd	shenzhen Guangdong, China	Manufacturer	api.fda.gov
Huanghua Promisee Dental Co., Ltd	Huanghua Hebei, China	Manufacturer	api.fda.gov
Infitek Co., Ltd.	Shanghai, China	Manufacturer	api.fda.gov
JWD. Technologies (jiangmen) Co.,ltd.	Jiangmen Guangdong, China	Exporter to the US, Manufacturer	api.fda.gov
Labpeak Co.,ltd	Jinan Shandong, China	Exporter to the US, Manufacturer	api.fda.gov
Little Doctor Electronic(nantong) Co.,ltd	Nantong Jiangsu, China	Specification developer	api.fda.gov
Liaoning JRSD Commercial AND Trading Co.,Ltd.	Shenyang Liaoning, China	Manufacturer	api.fda.gov
Ningbo Albert Novosino Co., Ltd.	Yuyao Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Ningbo Sun-Lite International Ltd.	NINGBO Zhejiang, China	Manufacturer	api.fda.gov
Ningbo Yongjin Medical Instruments Manufacture Co., Ltd.	Ningbo Zhejiang, China	Manufacturer	api.fda.gov
Ruian Sunnyworld International Trade Co.,ltd	RUIAN Zhejiang, China	Manufacturer	api.fda.gov
Scitek Global Co.,ltd	Jinan Shandong, China	Exporter to the US, Manufacturer	api.fda.gov
Shanghai Link Instruments Co.,ltd	Changzhou City Jiangsu, China	Manufacturer	api.fda.gov
Shenzhen Balinda Technology Co.,ltd	Shenzhen Guangdong, China	Exporter to the US, Manufacturer	api.fda.gov
Shenzhen Besdata Technology Co.,ltd	Shenzhen Guangdong, China	Manufacturer	api.fda.gov
Shenzhen Coreray Technology Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	api.fda.gov
Shenzhen Jie Bishi Technology Co., Ltd	Shenzhen Guangdong, China	Exporter to the US, Manufacturer	api.fda.gov
Shenzhen Alex Technology Co., Ltd.	Shenzhen Guangdong, China	Exporter to the US, Manufacturer	api.fda.gov
Taihu Huamei Medical Equipment Co.,ltd	Anqing City Anhui, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Vastrade Manufacturing Corporation	Shenzhen Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler	api.fda.gov
Wenzhou Caretek Medical Device Co., Ltd	Wenzhou Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Wenzhou Dongfang Medical Instruments Co., Ltd	WENZHOU Zhejiang, China	Contract manufacturer, Manufacturer	api.fda.gov
Wenzhou Longwan Medical Device Factory	Wenzhou Zhejiang, China	Manufacturer	api.fda.gov
Wenzhou Renhua Instruments Co.,ltd	WENZHOU Zhejiang, China	Manufacturer	api.fda.gov
Xuzhou AKX Electronic Science and Technology Co., Ltd.	Xuzhou Jiangsu, China	Manufacturer	api.fda.gov
Yilian Yike (shenzhen) Technology Co., Ltd.	Shenzhen Guangdong, China	Exporter to the US, Remanufacturer	api.fda.gov
Zhejiang Honsun Medical Technology Co., Ltd.	Wenzhou City Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Zumax Medical Co, Ltd.	Suzhou,Jiangsu, China	Contract manufacturer, Manufacturer	api.fda.gov
Zhejiang Gongdong Medical Technology Co., Ltd	TAIZHOU Zhejiang, China	Manufacturer	api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.