FDA Registration
Active
🇨🇳 China
Blood Pressure Cuff (Inactive)
Reg #: 3010362947
·
FEI: 3010362947
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Shenzhen Vital Signs-KTL Medical Instrument Co Ltd
- Registration Number
- 3010362947
- FEI Number
- 3010362947
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building 3, NO.88 North Jiaoyu Road, Gaoqiao Industrial Park, Pingdi, Longgang District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K844988
Owner / Operator
- Firm Name
- SunMed Group Holdings, LLC dba AirLife
- Operator Number
- 10044795
- Address
- 2710 Northridge Drive NW, Suite A
- City
- Grand Rapids
- State
- MI
- Postal Code
- 49544
- Country
- US
- Correspondent
- Rob Yamashita
US Agent
- Business Name
- SunMed Group Holdings LLC, dba AirLife
- Contact Name
- Rob Yamashita
- Address
- 2710 Northridge Dr Nw Ste A
- City
- Grand Rapids
- State
- MI
- ZIP
- 49544
- Country
- US
- [email protected]
- Phone
- 616 2598373
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2013-08-01 |
Proprietary Names
Blood Pressure Cuff (Inactive)
Establishment Types
Repack or Relabel Medical Device