Shenzhen Witleaf Medical Electronics Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 4 device types, 1 product catalogued, 2 clearances.
Shenzhen Witleaf Medical Electronics Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Oximeter, Wellness and 2 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2023.
Registration
| Registered name | SHENZHEN WITLEAF MEDICAL ELECTRONICS CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3020924771 |
| FEI number | 3020924771 |
| DUNS | 403635526 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市惟拓力医疗电子有限公司 |
|---|---|
| Unified social credit code | 914403000940768221 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Room 1201, Building 1, Senyang Electronic Technology Park, West Area, Guangming High-tech Park |
| Postal code | 518132 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Airway, Nasopharyngeal | Class 1 | Nasopharyngeal airway for oxygenation and capnography (model: iway 13, iway 15) | 2023 | 52 |
| Oximeter | Class 2 | Handheld Pulse Oximeter (model: WIT-S100, WIT-S300, CH-100B), Fingertip Pulse Oximeter (model: WIT-S200, WIT-S400) | 2023 | 70 |
| Oximeter, Infrared, Sporting, Aviation | Class 2 | Pulse Oximeter (model: CH-100) | 2024 | 29 |
| Oximeter, Wellness | Class 2 | Handheld Pulse Oximeter CH-100; Wellness Oximeter | 2023 | 19 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| iWay | BTQ | 2 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K213431 | 2023-02-26 | DQA | Traditional | This company |
| K213430 | 2022-12-30 | DQA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2013 |
|---|---|
| Main products | Patient monitors, Pulse oximeters, Blood pressure monitors, Capnography systems, ECG systems |
| Certifications | EU MDR, High-tech Enterprise, CE, FDA |
| 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.