Data / Medical devices / China / Dragon Heart Medical Devices Co., Ltd.
Dragon Heart Medical Devices Co., Ltd.: FDA-registered device maker in Kaiping Guangdong, China, 2 510(k) clearances
Dragon Heart Medical Devices Co., Ltd. is registered with the FDA (registration 3004215921) in Kaiping Guangdong, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 18, 2010. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004215921
- Address
- 28 Ruliang Road, Baihe Town, Kaiping Guangdong, China, 529375
- Owner or operator
- DRAGON HEART MEDICAL DEVICES CO., LTD. (9059702)
- Roles
- Manufacturer
- First device listed
- November 14, 2003
- Registered through
- 2027
- Brand names listed
- D.H. Medical IV Set, DH Medical Blood Holder, IV Set
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 18, 2010 | K101368 | D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES | FPA | Substantially Equivalent | Dragon Heart Medical, Inc. | accessdata.fda.gov |
| March 8, 2005 | K043235 | DRAGON HEART I.V. SET | FPA | Substantially Equivalent | Dragon Heart Medical Devices Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Blood Collection, Vacuum-Assisted, Manual
- All makers of Set, Administration, Intravascular
Updated November 18, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.