Shenzhen Hexin Zondan Medical Equipment Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 3 device types, 3 products catalogued, 1 clearance.
Shenzhen Hexin Zondan Medical Equipment Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Oximeter, Wellness and 1 other device type. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007858728 |
| FEI number | 3007858728 |
| DUNS | 527098717 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市和心重典医疗设备有限公司 |
|---|---|
| Unified social credit code | 91440300743221218R |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Floor 14, Block D,Dianlian Technology Building, the Crossing between South Circle Road and South Fuli Road |
| Postal code | 518106 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Oximeter | Class 2 | Pulse oximeter | 2021 | 70 |
| Oximeter, Infrared, Sporting, Aviation | Class 2 | FL400, 500DL, C7, CCI-50DL, PX-560BTCO, 85301 and 18 more | 2025 | 29 |
| Oximeter, Wellness | Class 2 | Pulse oximeter, A2, 11-50K, C4, 90-50D, C3 and 25 more | 2020 | 19 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K203854 | 2021-04-23 | DQA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | patient monitors, fetal monitors, fetal dopplers, pulse oximeters |
|---|
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.