Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd.
Registered establishment in Huizhou, Guangdong, China. 3 device types, 6 clearances.
Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Clamp, Vascular, Apparatus, Exhaust, Surgical and 1 other device type. Its earliest product listing with the FDA dates from 2009.
Registration
| Registered name | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010601992 |
| FEI number | 3010601992 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer |
Chinese Registration
| Chinese legal name | 荣佳（惠州）医疗器械制造有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Huizhou |
|---|---|
| Province | Guangdong |
| Address | Tang Jiao Xing Wang Street, Lilin Town, ZhongKai Hi-Tech Zone |
| Postal code | 516035 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Apparatus, Exhaust, Surgical | Class 2 | 2019 | 3 | |
| Clamp, Vascular | Class 2 | Omed Disposable Bulldog | 2017 | 10 |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | 4cm TUNGSTEN MICRONEEDLE(Model:138506,138506-10), Electrosurgical Pencil with electrode,model:WP200,WP200-B100S,WP200-C100S,WP200-L31S,WP200-N100S,WP200-B90S, 3cm TUNGSTEN MICRONEEDLE(Model:138505,138505-10), 45 degree TUNGSTEN MICRONEEDLE(Model:138504,138504-10), medline | 2009 | 65 |
Clearances
6 clearances name Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K241022 | 2024-07-11 | GEI | Traditional | This company |
| K222828 | 2023-03-20 | GCJ | Traditional | This company |
| K172578 | 2017-12-07 | GCJ | Traditional | This company |
| K172794 | 2017-11-29 | GCJ | Traditional | This company |
| K172038 | 2017-10-27 | GCJ | Traditional | This company |
| K172120 | 2017-09-14 | FHO | Traditional | This company |
| K100258 | 2010-04-28 | GEI | Abbreviated | Wickimed Supply Company Limited. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2006 |
|---|---|
| Main products | surgical instruments, medical equipment, sterile disposables |
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.