Shanghai Berry Electronic Tech Co., Ltd.
Manufacturer and brand owner in Shanghai, China. 3 device types, 13 products catalogued, 3 clearances.
Shanghai Berry Electronic Tech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Oximeter, Wellness and 1 other device type. 13 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2015.
3device types registered with the FDA
13products catalogued under its own name
3510(k) clearances
Registration
| Registered name | SHANGHAI BERRY ELECTRONIC TECH CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009241523 |
| FEI number | 3009241523 |
| DUNS | 529404533 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 上海贝瑞电子科技有限公司 |
|---|---|
| Unified social credit code | 913101127547839537 |
| Source | NMPA UDI database |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | Unit 104 1st Floor 7th Building No. 1188 |
| Postal code | 201112 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Oximeter | Class 2 | BM1000D, BM1000B, BM1000, rx only, BM1000C, BM1000E and 4 more | 2015 | 70 |
| Oximeter, Infrared, Sporting, Aviation | Class 2 | ABPM02F, CP-50BLE CP-500E, Fingertip Pulse Oximeter BM2000A,BM1000A,BM1000B,BM1000C,BM1000,BM1000D,BM1000E, DHW-100, Fingertip Pulse Oximeter-SM-519BR-BL, INT-XM0001 and 6 more | 2018 | 29 |
| Oximeter, Wellness | Class 2 | BM2000A, BM20, BM1000, Berry Wellness | 2024 | 19 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Berry®贝瑞 | DQA | 6 |
| Berry® | OCH | 4 |
| NatureSpirit® | OCH | 2 |
| Santamedical | OCH | 2 |
| Danavi | OCH | 1 |
| iHeart™ | OCH | 1 |
| Aluratek | OCH | 1 |
| Binacor | OCH | 1 |
| IntiMD | OCH | 1 |
| Higcab | OCH | 1 |
| Dark Lightning | OCH | 1 |
| TeleRPM | DQA | 1 |
| Iguanamed | OCH | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K250837 | 2025-09-25 | DQA | Traditional | This company |
| K172141 | 2018-04-04 | DQA | Traditional | This company |
| K142687 | 2015-04-13 | DQA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Main products | Pulse oximeters, Patient monitors, ECG/EKG accessories, Infusion pumps, OEM modules |
| Certifications | CE, FDA, ISO13485, ANVISA, INMETRO |
| Export markets | 100+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.