FDA Registration
Active
🇨🇳 China
M800 Handheld Monitor
Reg #: 3007305624
·
FEI: 3007305624
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- GUANGDONG BIOLIGHT MEDITECH CO., LTD
- Registration Number
- 3007305624
- FEI Number
- 3007305624
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.9 Yonghe Road, Hi-tech Zone
- City
- Zhuhai Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K131762
Owner / Operator
- Firm Name
- Guangdong Biolight Meditech Co., Ltd
- Operator Number
- 10027195
- Address
- No.2 Innovation First Road, Technology, Innovation Coast, Hi-tech Zone
- City
- Zhuhai
- State
- Guangdong
- Postal Code
- 519085
- Country
- CN
- Correspondent
- Jinyuan Yan
US Agent
- Business Name
- MID-LINK INTERNATIONAL Co., Ltd
- Contact Name
- Marco Mu
- Address
- 2219 Rimlang Drive,Suite 301
- City
- Bellingham-Barkley Villiage
- State
- WA
- ZIP
- 98226
- Country
- US
- [email protected]
- Phone
- 702 2095185
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2016-08-31 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2016-08-31 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2016-08-31 |
Proprietary Names
M800 Handheld Monitor
Establishment Types
Manufacture Medical Device