MedHealth Medical Limited
Manufacturer and brand owner in Shenzhen, Guangdong, China. 2 device types, 2 products catalogued, 1 clearance.
MedHealth Medical Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Tourniquet, Pneumatic, Sleeve, Limb, Compressible. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2013.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3010190204 |
| FEI number | 3010190204 |
| DUNS | 526120281 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市迈合医疗器械有限公司 |
|---|---|
| Unified social credit code | 914403007716244873 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 701/101, BLDG 24, Block B, Yuanshan Zone, Shangcun, Gongming |
| Postal code | 518106 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Sleeve, Limb, Compressible | Class 2 | VasoGrad Garment, VasoPress Garment, Foot Garment, Circassist DVT Prophylaxis Sleeve, ALP 1SM Calf Garment; ALP 2 Calf Garment; ALP 2XL Garment; ALP 2XXL Calf Garment; ALP 3 Thigh Garment;, ALP 1 Calf Garment; ALP 1A Calf Garment and 6 more | 2013 | 24 |
| Tourniquet, Pneumatic | Class 1 | Cyl.Cuff DPDB(T90410,T90420,T90430,T90440,T90450,T90460,T90470, T90411,T90421,T90431,T90441,T90451,T90461,T90471), Cyl.Cuff SPDB(T90310,T90320,T90330,T90340,T90350,T90360,T90370, T90311,T90321,T90331,T90341,T90351,T90361,T90371), Cyl.Cuff SPSB(T90110,T90120,T90130,T90140,T90150,T90160,T90170, T90111,T90121,T90131,T90141,T90151,T90161,T90171), Cyl.Cuff DPSB(T90210,T90220,T90230,T90240,T90250,T90260,T90270, T90211,T90221,T90231,T90241,T90251,T90261,T90271) | 2024 | 21 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| MedHealth | JOW | 17 |
| Circassist | JOW | 2 |
Clearances
1 clearance names MedHealth Medical Limited as applicant. 4 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 |
|---|---|---|---|---|
| K231801 | 2023-12-14 | JOW | Traditional | This company |
| K201532 | 2020-09-19 | JOW | Traditional | B&J Manufacturing, Ltd. |
| K201547 | 2020-09-18 | JOW | Traditional | B&J Manufacturing, Ltd. |
| K200568 | 2020-07-10 | JOW | Traditional | B&J Manufacturing, Ltd. |
| K200154 | 2020-07-08 | JOW | Traditional | B&J Manufacturing, Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Employees | 150 |
| Factory area | 5000 m² |
| Main products | DVT Pump, DVT Sleeve, Tourniquet, Pulse Lavage System, Lymphedema devices |
| Certifications | FDA, ISO 13485, NMPA, CE, 510K, GMP |
| Export markets | 40+ countries |
| 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.