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Sign in to claim this brandSHANGHAI BERRY ELECTRONIC TECH CO., LTD.
US
Last updated May 30, 2026
What SHANGHAI BERRY ELECTRONIC TECH CO., LTD. makes
The company manufactures pulse oximeters, including portable and wearable models designed for monitoring blood oxygen saturation and pulse rate. Examples include devices like the DANAVI, Dark Lightning, and the BERRY® series, as well as telemedicine-enabled solutions such as TeleRPM and IntiMD. Some products are branded under SANTAMEDICAL and BINACOR.
These devices are regulated as Class II medical devices in the US, with authorisation through FDA pathways including the 510(k) process and the Unique Device Identifier (UDI) system. The company’s products are listed under these regulatory frameworks, and the manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Shanghai Berry Electronic Tech Co., Ltd. primarily manufacture?
Shanghai Berry Electronic Tech Co., Ltd. specializes in pulse oximeters, which are devices used to measure blood oxygen saturation (SpO₂) and pulse rate. These include portable and wearable models, such as the DANAVI, Dark Lightning, and multiple variants of the BERRY® series. Some products also incorporate telemedicine features, like the TeleRPM and IntiMD systems, expanding their use in remote patient monitoring.
Where is Shanghai Berry Electronic Tech Co., Ltd. based, and how does this affect its regulatory compliance?
The company is based in the United States, which means its devices are subject to FDA regulations. Since pulse oximeters fall under Class II classification in the US, they require authorisation through pathways like the 510(k) process or compliance with the Unique Device Identifier (UDI) system. The FDA listings confirm these devices meet applicable regulatory standards for safety and performance.
Which regulatory registries or databases list Shanghai Berry Electronic Tech Co., Ltd.’s devices?
The company’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries ensure transparency about device authorisation status, manufacturing details, and compliance with US medical device regulations, helping healthcare providers verify product legitimacy and regulatory clearance.
How are Shanghai Berry Electronic Tech Co., Ltd.’s pulse oximeters classified under US regulations?
The company’s pulse oximeters are classified as Class II medical devices in the US. This classification is based on their intended use—non-invasive monitoring of blood oxygen levels and pulse rate—which poses moderate risk. Class II devices require special controls beyond general controls to ensure safety and effectiveness, including pathways like the 510(k) or UDI compliance to demonstrate regulatory authorisation.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- [email protected]
- Phone
- +86 13425179169
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 529404533
Catalogue (24)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Danavi | DHW-100 | FDA UDI | Class II | Active |
| Berry® | BM1000D | FDA UDI | Class II | Active |
| Berry®贝瑞 | BM1000A | FDA UDI | Class II | Active |
| Dark Lightning | BM1000 | FDA UDI | Class II | Active |
| Santamedical | SM-519BR-BL | FDA UDI | Class II | Active |
| Binacor | BC3500 | FDA UDI | Class II | Active |
| Berry® | BM1000C | FDA UDI | Class II | Active |
| Berry® | BM1000E | FDA UDI | Class II | Active |
| Berry® | BM1000B | FDA UDI | Class II | Active |
| Berry®贝瑞 | BM1000C | FDA UDI | Class II | Active |
| TeleRPM | BM1000 | FDA UDI | Class II | Active |
| IntiMD | INT-XM0001 | FDA UDI | Class II | Active |
| iHeart™ | BM1000B | FDA UDI | Class II | Active |
| Aluratek | ABPM02F | FDA UDI | Class II | Active |
| Santamedical | BM1000 | FDA UDI | Class II | Active |
| Iguanamed | IGA10020 | FDA UDI | Class II | Active |
| Higcab | BM1000 | FDA UDI | Class II | Active |
| Berry®贝瑞 | BM1000 | FDA UDI | Class II | Active |
| NatureSpirit® | CP-500E | FDA UDI | Class II | Active |
| Berry®贝瑞 | BM2000A | FDA UDI | Class II | Active |
| NatureSpirit® | CP-50BLE | FDA UDI | Class II | Active |
| Pulse Oximeter | K142687 | FDA 510(k) | Class II | Active |
| Pulse Oximeter | K172141 | FDA 510(k) | Class II | Active |
| Pulse Oximeter | K250837 | FDA 510(k) | Class II | Active |
Related Companies
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Authorities
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Shanghai Berry Electronic Tech Co., Ltd. Shanghai · CN FEI 3009241523