Shenzhen Homed Medical Device Co Ltd
Manufacturer and brand owner in Shenzhen, Guangdong, China. 13 device types, 4 products catalogued, 4 clearances.
Shenzhen Homed Medical Device Co Ltd is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Oxygen, Tubing, Noninvasive and 11 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2012.
Registration
| Registered name | SHENZHEN HOMED MEDICAL DEVICE CO LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010287621 |
| FEI number | 3010287621 |
| DUNS | 421309081 |
| Establishment type | Contract manufacturer, Specification developer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳市新鸿镁医疗器械有限公司 |
|---|---|
| Unified social credit code | 914403007525138375 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Room 1601-1614, A Building , Jinxiu III, No.85 Hudi Pai |
| Postal code | 518109 |
| Country | China |
What It Makes
Own-Brand Listings
Clearances
4 clearances name Shenzhen Homed Medical Device Co Ltd as applicant. 2 are held by other companies 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 |
|---|---|---|---|---|
| K252616 | 2025-12-22 | CAW | Traditional | This company |
| K212395 | 2022-03-25 | CAF | Traditional | This company |
| K170886 | 2018-06-21 | CAF | Traditional | This company |
| K161586 | 2017-09-06 | CAF | Traditional | This company |
| K150591 | 2015-06-30 | CAF | Traditional | Besmed Health Business Corporation |
| K020932 | 2002-06-28 | CAF | Traditional | Sunrise Medical International Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | respiratory detection, respiratory care, home nebulization, critical respiratory support, respiratory rehabilitation |
|---|---|
| Certifications | Internet Drug Information Service License |
| Export markets | overseas |
| OEM and ODM | Offered |
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.