FDA Registration
Active
🇨🇳 China
Colormetric etCO2 detector (MaxCap)
Reg #: 3005998497
·
FEI: 3005998497
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SUNMED AP, LTD.
- Registration Number
- 3005998497
- FEI Number
- 3005998497
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6-9 ZHUFENG RD., QIANNAN INDUSTRIAL PARK, QIANWU TOWN, DOUMEN DISTRICT
- City
- ZHUHAI Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K133540
Owner / Operator
- Firm Name
- VENTLAB, LLC
- Operator Number
- 2246980
- Address
- 2710 Northridge Dr. NW, Suite A, --
- City
- Grand Rapids
- State
- MI
- Postal Code
- 49544
- Country
- US
- Correspondent
- Rob Yamashita
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2024-08-27 |
Proprietary Names
Colormetric etCO2 detector (MaxCap)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)