Suzhou Minhua Medical Equipment Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 9 device types.
Suzhou Minhua Medical Equipment Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Blood Pressure Cuff, Cushion, Wheelchair and 7 other device types. Its earliest product listing with the FDA dates from 2015.
Registration
| Registered name | Suzhou Minhua Medical Equipment Co.,Ltd. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011529836 |
| FEI number | 3011529836 |
| Establishment type | Contract manufacturer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 苏州敏华医疗器材配套有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | No. 789 Wufang Road YouYi Industrial Park |
| Postal code | 215222 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Blood Pressure Cuff | Class 2 | Connector,adapter, Medline Singe Patient Use Blood Pressure Cuff, NBP Cuff for Adult; NBP Cuff for Child; NBP Cuff for Infant; NBP Cuff for Neonates; NBP extension hose /adapter, Reusable Blood Pressure Cuff Over-The-Counter Use, Medline Reusable Blood Pressure Cuff | 2015 | 50 |
| Cushion, Wheelchair | Class 1 | 2022 | 53 | |
| Infusor, Pressure, For I.V. Bags | Class 1 | 2015 | 25 | |
| Mattress, Flotation Therapy, Non-Powered | Class 1 | 2023 | 30 | |
| Pack, Hot Or Cold, Water Circulating | Class 2 | ICEFLOW Cold Therapy System | 2017 | 45 |
| Protector, Skin Pressure | Class 1 | 2017 | 101 | |
| Sleeve, Limb, Compressible | Class 2 | Lympha Press Leg 4, Venera 608 Deep Vein Thrombosis (DVT) Prevention System, Medline Hemo-Force DVT Compression Sleeve | 2018 | 24 |
| Strap, Head, Gas Mask | Class 1 | 2018 | 29 | |
| Support, Patient Position | Class 1 | Strap, Positioning, Knee/Body Cotton, 4″x60″ | 2021 | 66 |
Clearances
No clearance names Suzhou Minhua Medical Equipment Co., Ltd. as applicant. 5 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 |
|---|---|---|---|---|
| K241096 | 2025-01-15 | JOW | Traditional | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. |
| K233276 | 2023-12-21 | DXQ | Traditional | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. |
| K180389 | 2018-06-29 | JOW | Traditional | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. |
| K171889 | 2017-12-19 | DXQ | Traditional | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. |
| K143728 | 2015-05-15 | DXQ | Traditional | Suzhou Minhua Medical Apparatus |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1993 |
|---|---|
| Main products | Rehabilitation equipment, Blood pressure cuffs, Medical accessories, First aid supplies |
| Certifications | ISO 13485, FDA audit passed twice |
| 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.