Data / Medical devices / China / Shenzhen Homed Medical Device Co Ltd
Shenzhen Homed Medical Device Co Ltd: FDA-registered device maker in Dongguan Guangdong, China, 3 510(k) clearances
Shenzhen Homed Medical Device Co Ltd is registered with the FDA (registration 3013000203) in Dongguan Guangdong, China. It lists 14 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 21, 2018. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013000203
- Address
- Block 5, 2 Anyue Road, Chashan Town,Dongguan City 523393, Guangdong Province, People's Republic of China, Dongguan Guangdong, China, 523393
- Owner or operator
- Shenzhen Homed Medical Device Co., Ltd (10041952)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- September 23, 2012
- Registered through
- 2026
- Brand names listed
- APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED, BYX - TUBING, PRESSURE AND ACCESSORIES, Compressor Nebulizer, Curelief Purabreathe Mesh Nebulizer, MASK, OXYGEN, MOUTHPIECE, BREATHING, Nebulizer, SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Manufacturer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Manufacturer | accessdata.fda.gov |
| Compressor, Air, Portable | BTI | 2 | Exporter to the US | accessdata.fda.gov |
| Generator, Oxygen, Portable | CAW | 2 | Contract manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Manufacturer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Manufacturer | accessdata.fda.gov |
| Nasal Spray, Ent Delivery | KCO | 1 | Manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Manufacturer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Manufacturer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Contract manufacturer | accessdata.fda.gov |
| Tubing, Noninvasive | GAZ | 2 | Manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Filter, Membrane | JRL | 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 |
|---|---|---|---|---|---|---|
| June 21, 2018 | K170886 | HOMED Mesh Nebulizer | CAF | Substantially Equivalent | Shenzhen Homed Medical Device Co., Ltd. | accessdata.fda.gov |
| June 30, 2015 | K150591 | Besmed Reusable Jet Nebulizer | CAF | Substantially Equivalent | Besmed Health Business Corp | accessdata.fda.gov |
| June 28, 2002 | K020932 | DEVILBISS PULMO-AIDE COMPACT COMPRESSOR | CAF | Substantially Equivalent | Sunrise Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Generator, Oxygen, Portable
- All makers of Unit, Filter, Membrane
- All makers of Set, Tubing And Support, Ventilator (W Harness)
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Tubing, Pressure And Accessories
- All makers of Sleeve, Limb, Compressible
Updated June 21, 2018. 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.