FDA Registration
Active
🇨🇳 China
Multi-parameter Patient Monitor,Model C30
Reg #: 3008716327
·
FEI: 3008716327
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD.
- Registration Number
- 3008716327
- FEI Number
- 3008716327
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Floor 10, Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of Building 2, FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district, Guangming District, Shenzhen, 518106, Guangdong
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K173454
Owner / Operator
- Firm Name
- Shenzhen Comen Medical Instruments Co., Ltd.
- Operator Number
- 10042479
- Address
- Floor10, Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of Building 2, FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district, Guangming District, Shenzhen, 518106, Guangdong
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518106
- Country
- CN
- Correspondent
- Gang Duan
US Agent
- Business Name
- Biologics Consulting
- Contact Name
- MARGARET VERNON
- Address
- 100 DAINGERFIELD ROAD, SUITE 400
- City
- Alexandria
- State
- VA
- ZIP
- 22314
- Country
- US
- [email protected]
- Phone
- 720 8833633
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2018-08-20 |
Proprietary Names
Multi-parameter Patient Monitor,Model C30
Establishment Types
Manufacture Medical Device