Shenzhen Boon Medical Supply Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 1 device type, 10 products catalogued, 3 clearances.
Shenzhen Boon Medical Supply Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Injector And Syringe, Angiographic. 10 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3012395857 |
| FEI number | 3012395857 |
| DUNS | 529174252 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市保安医疗用品有限公司 |
|---|---|
| Unified social credit code | 91440300618836774Q |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | No.18 Jirong Road, Shenkeng, Henggang Street, Longgang District |
| Postal code | 518173 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Injector And Syringe, Angiographic | Class 2 | Sterile High-Pressure Angiographic Syringes For Single-Use, Boon, Connection tube, Models: 400204, Sterile High-Pressure Angiographic Syringes For Single-Use, Models: 100123, 100125, 100110, 100120, 100112, 100122, Sterile High-Pressure Angiographic Syringes For Single-Use, Models: 300107, 200105, 200113, 200110, 200111, Transfer set, Models: 700204-1, 700204-2, 700205-1, 700205-2, 700206, 700207-1, 700207-2 and 54 more | 2016 | 15 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Sinton Medical Products | DXT | 199 |
| Medical Imaging Solutions International | DXT | 43 |
| LF | DXT | 38 |
| SpectraVue | DXT | 21 |
| Steriatrics | DXT | 19 |
| Genus | DXT | 18 |
| Guerbet | DXT | 15 |
| Boon | DXT | 11 |
| MED-RX | DXT | 5 |
| DeRoyal | DXT | 1 |
Clearances
3 clearances name Shenzhen Boon Medical Supply Co., Ltd. as applicant. 2 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 |
|---|---|---|---|---|
| K241109 | 2024-08-22 | DXT | Traditional | This company |
| K211564 | 2021-10-19 | DXT | Traditional | This company |
| K192657 | 2020-08-07 | DXT | Traditional | This company |
| K182289 | 2018-10-10 | DXT | Special | Shenzhen Baoan Medical Supplies Co., Ltd. |
| K151960 | 2016-01-07 | DXT | Traditional | Shenzhen Baoan Medical Supplies Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1990 |
|---|---|
| Factory area | 80,000 square meters |
| Main products | Syringes, Angiographic syringes, Infusion sets, Obstetric surgical products, Clinical examination devices |
| Certifications | ISO 9001, ISO 13485, CE, FDA 510K, MDSAP, KFDA |
| Export markets | North America, Eastern Europe, Africa, Middle East, Eastern Asia, Western Europe |
| 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.