Shanghai Berry Electronic Tech Co., Ltd. – Medical Device Regulatory and Product FAQ

Question 1

How does Shanghai Berry Electronic Tech Co., Ltd. verify the accuracy of SpO2 and pulse rate measurements in its pulse oximeters?

Accepted Answer

Shanghai Berry Electronic Tech Co., Ltd. develops pulse oximeters based on photoelectric oxyhemoglobin inspection technology using red and infrared light and pulse-wave (PPG) analysis to measure functional arterial oxygen saturation (SpO2) and pulse rate. Devices are verified using in-house medical test equipment such as SpO2 simulators and multi-parameter simulators under an EN ISO 13485 quality management system certified by TÜV SÜD and with production licensing by the Shanghai FDA. Berry pulse oximeters have obtained US FDA 510(k) clearance and EU CE0123 certification, which require bench and clinical performance data against reference devices. Public specifications describe operation under low perfusion and anti-ambient-light interference; however, separate numerical accuracy datasets stratified by skin pigmentation are not published on the website.

Question 2

Are Berry portable and Bluetooth pulse oximeters intended for clinical monitoring or only for fitness and wellness use?

Accepted Answer

Berry fingertip, handheld and wrist pulse oximeters are described as suitable for use in family, hospital, oxygen bar, community healthcare and similar medical monitoring environments, and usage instructions indicate they can be used before or after exercise but are not recommended during exercise. Company information and product pages state that many Berry devices have obtained EN ISO 13485 certification, CE (CE0123) certification by TÜV SÜD and FDA 510(k) clearance, identifying them as medical devices. Some products in the catalog are clearly labeled for veterinary use only and are not medical devices for human patients, which distinguishes clinical human monitors from animal-only equipment.

Question 3

How can users verify the difference between Berry’s FDA establishment registration and FDA 510(k) clearance for its devices?

Accepted Answer

Berry is listed in FDA databases as a registered medical device manufacturer with Facility Establishment Identifier (FEI) 3009241523 at Unit 104, 1st Floor, 7th Building, No. 1188 Lianhang Road, Minhang District, Shanghai 201112, China. This registration identifies the manufacturing establishment. Separately, Berry holds specific 510(k) clearances for its pulse oximeters, including K250837 and K172141, which classify the devices as Class II oximeters and document substantial equivalence to predicate devices. Users can verify both the establishment registration and individual 510(k) clearances by searching the public FDA registration and 510(k) databases using the company name and these identifiers.

Question 4

What regulatory certifications and quality management systems does Shanghai Berry Electronic Tech Co., Ltd. hold for its medical devices?

Accepted Answer

In 2009 Shanghai Berry Electronic Tech Co., Ltd. obtained a medical device production license and product registration certificate issued by the Shanghai FDA. In 2014 the company passed EN ISO 13485 quality management system certification and received CE0123 certification by TÜV SÜD for its medical devices. The company obtained FDA 510(k) clearance for pulse oximeters for the US market and later 510(k) clearance for fingertip pulse oximeters, and reports further approvals including ANVISA and INMETRO for certain products. Selected product pages also list CE, FDA(510k), ISO13485, FCC and RoHS for specific models such as handheld and wrist oximeters and sleep apnea screening monitors.

Question 5

How does Berry address data privacy when Bluetooth pulse oximeters send health data to smartphone apps and remote monitoring systems?

Accepted Answer

Berry remote patient monitoring devices and multi-parameter monitors connect to smartphone apps such as Berry Smart Health via Bluetooth (e.g., Bluetooth 5.0) and can upload SpO2, pulse rate and other vital-sign data to cloud or server-based systems using Wi-Fi, 4G and related technologies. Product descriptions for remote monitoring oximeters state that they are designed as medical remote patient monitoring devices with FDA and FCC approvals and that they are compliant with HIPAA requirements, indicating that the systems are intended to follow healthcare data-protection rules. The company does not publish a separate public document on the website detailing data storage locations, retention times or GDPR implementation, so users should confirm these details via product documentation or direct contact when deploying systems in specific jurisdictions.

Question 6

What are the main product categories manufactured by Shanghai Berry Electronic Tech Co., Ltd.?

Accepted Answer

According to the company profile and FAQ pages, Shanghai Berry Electronic Tech Co., Ltd. focuses on medical electronic instruments including sleep apnea screening monitors, pulse oximeters, multi-parameter patient monitors, veterinary monitors, disposable and reusable SpO2 sensors, NIBP cuffs and hoses, ECG and temperature probes, remote patient monitoring systems and wireless OEM modules. The company also manufactures home health devices such as nebulizers and related accessories.

Question 7

In which regions are Berry medical devices distributed and how many countries do they reach?

Accepted Answer

Company and distributor profiles state that Berry medical devices are exported to more than 80 countries according to the FAQ and to more than 130 countries and regions according to international trade listings. Major markets include Europe, the United States, Asia, Africa, Oceania, the Middle East and other regions, supported by multiple production bases and participation in international medical exhibitions such as Arab Health, CMEF, Hospitalar, FIME and Medica.

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