FDA Registration
Active
🇨🇳 China
HYDROVEN FPR PUMP (SUZHOU - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE)
Reg #: 3005619970
·
FEI: 3005619970
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Arjo (Suzhou) Co., Ltd.
- Registration Number
- 3005619970
- FEI Number
- 3005619970
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 158 Fangzhou Road, SIP, Suzhou, Jiangsu,
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K910188
Owner / Operator
- Firm Name
- ARJOHUNTLEIGH AB
- Operator Number
- 8010077
- Address
- Hans Michelsensgatan 10
- City
- Malmo
- State
- Skane
- Postal Code
- 211 20
- Country
- SE
US Agent
- Business Name
- Arjo Inc
- Contact Name
- Darren Demerritt
- Address
- 2349 W Lake St, #250
- City
- Addison
- State
- IL
- ZIP
- 60101
- Country
- US
- [email protected]
- Phone
- 425 3089587
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2007-12-05 |
Proprietary Names
HYDROVEN FPR PUMP (SUZHOU - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE)
HYDROVEN GARMENTS (POZNAN - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE)
HYDROVEN 3 PUMP (SUZHOU - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)