Shenzhen Antmed Co., Ltd.
Manufacturer and brand owner in Dongguan, Guangdong, China. 4 device types, 4 products catalogued.
Shenzhen Antmed Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Syringe, Balloon Inflation, Injector And Syringe, Angiographic and 2 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
Registration
| Registered name | SHENZHEN ANTMED CO. LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007048453 |
| FEI number | 3007048453 |
| DUNS | 527221254 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳安特医疗股份有限公司 |
|---|---|
| Unified social credit code | 91440300758649954X |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | No.3 Hualian Ave., Songshanhu District |
| Postal code | 523800 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheter, Intravascular, Diagnostic | Class 2 | Pressure Connecting Tube | 2014 | 11 |
| Injector And Syringe, Angiographic | Class 2 | ANT Angiographic Syringes | 2008 | 15 |
| Syringe, Balloon Inflation | Class 2 | ANT Inflation Device and ANT Inflation Device Compact Pack | 2011 | 6 |
| Transducer, Blood-Pressure, Extravascular | Class 2 | Disposable Pressure Transducer | 2009 | 7 |
Own-Brand Listings
Clearances
No clearance names Shenzhen Antmed Co., Ltd. as applicant. 4 are 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 |
|---|---|---|---|---|
| K131770 | 2014-02-26 | DQO | Traditional | Shenzhen Ant Hi-Tech Industrial Co., Ltd. |
| K102648 | 2011-07-01 | MAV | Traditional | Shenzhen Ant Hi-Tech Industrial Co., Ltd. |
| K091408 | 2009-08-18 | DRS | Traditional | Shenzhen Ant Hi-Tech Industrial Co., Ltd. |
| K072696 | 2008-05-02 | DXT | Traditional | Shenzhen Ant Hi-Tech Industrial Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2000 |
|---|---|
| Main products | High-pressure injectors, Contrast delivery systems, Invasive pressure sensors, Cardiovascular intervention devices, Dental implant systems |
| Certifications | EU ISO 13485, US 21 CFR 820, MDSAP, EU MDR, US FDA 510(k), EcoVadis bronze |
| Export markets | 130+ countries |
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.