FDA Registration
Active
🇨🇳 China
Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor
Reg #: 3007305624
·
FEI: 3007305624
·
Expires 2025
Products
14
Proprietary Names
2
Establishment Types
1
Classifications
14
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
- K131763
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 |
|---|---|---|---|---|---|
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2013-08-29 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2013-08-29 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2013-08-29 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2013-08-29 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2013-08-29 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2013-08-29 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2013-08-29 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2013-08-29 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2013-08-29 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2013-08-29 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2013-08-29 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2013-08-29 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2013-08-29 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2013-08-29 |
Proprietary Names
Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor
Truscope Classic,Truscope II,Truscope MINI patient monitor
Establishment Types
Manufacture Medical Device