FDA Registration
Active
🇨🇳 China
Suzhou Minhua Medical Equipment Co.,Ltd.
Reg #: 3011529836
·
FEI: 3011529836
·
Expires 2026
Products
9
Proprietary Names
4
Establishment Types
5
Classifications
9
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Registration Details
- Registration Name
- Suzhou Minhua Medical Equipment Co.,Ltd.
- Registration Number
- 3011529836
- FEI Number
- 3011529836
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 789 Wufang Road YouYi Industrial Park
- City
- SuZhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K233276
Owner / Operator
- Firm Name
- Suzhou Minhua Medical Equipment Co.,Ltd.
- Operator Number
- 10048668
- Address
- No. 789 Wufang Road YouYi Industrial Park
- City
- Suzhou
- State
- Jiangsu
- Postal Code
- 215222
- Country
- CN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2026-04-30 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2024-01-25 |
| Cushion, Wheelchair | IMP | Class 1 | Physical Medicine | No | 2022-11-09 |
| Mattress, Flotation Therapy, Non-Powered | IKY | Class 1 | General Hospital | No | 2023-09-21 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2017-04-18 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2021-12-08 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2015-02-10 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2017-09-11 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2018-07-25 |
Proprietary Names
Reusable Blood Pressure Cuff Over-The-Counter Use
NBP Cuff for Adult; NBP Cuff for Child; NBP Cuff for Infant; NBP Cuff for Neonates; NBP extension hose /adapter
Medline Reusable Blood Pressure Cuff
ICEFLOW Cold Therapy System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Foreign Private Label Distributor
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Complaint File Establishment per 21 CFR 820.198