Dragon Heart Medical Devices Co., Ltd.
Registered establishment in Kaiping, Guangdong, China. 2 device types, 2 clearances.
Dragon Heart Medical Devices Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Set, Administration, Intravascular, System, Blood Collection, Vacuum-Assisted, Manual. Its earliest product listing with the FDA dates from 2003.
Registration
| Registered name | DRAGON HEART MEDICAL DEVICES CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004215921 |
| FEI number | 3004215921 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 广东龙心医疗器械有限公司 |
|---|---|
| Unified social credit code | 91440783617756502J |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Kaiping |
|---|---|
| Province | Guangdong |
| Address | 28 Ruliang Road, Baihe Town, |
| Postal code | 529375 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Set, Administration, Intravascular | Class 2 | D.H. Medical IV Set, IV Set | 2003 | 49 |
| System, Blood Collection, Vacuum-Assisted, Manual | Class 1 | DH Medical Blood Holder | 2005 | 31 |
Clearances
2 clearances name Dragon Heart Medical Devices 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 |
|---|---|---|---|---|
| K043235 | 2005-03-08 | FPA | Abbreviated | This company |
| K042547 | 2004-12-01 | FMF | Abbreviated | This company |
| K101368 | 2010-11-18 | FPA | Abbreviated | Dragon Heart Medical, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1982 |
|---|---|
| Factory area | 60000 square meters |
| Main products | IV catheters, Infusion sets, Syringes, Medical adhesive, Catheters |
| Certifications | CE, ISO13485, FDA, ISO9000 |
| Export markets | Asia, Europe, North America |
| OEM and ODM | Offered |
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.