FDA Registration
Active
🇬🇧 United Kingdom
G2 Wearable Device
Reg #: 3018188848
·
FEI: 3018188848
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- KEY-TECH SCOTLAND LTD
- Registration Number
- 3018188848
- FEI Number
- 3018188848
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Midfield Road Mitchelston Industrial Eastate
- City
- Dunfermline Fife
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K210133
Owner / Operator
- Firm Name
- Key-Tech Scotland LTD
- Operator Number
- 10080519
- Address
- Midfield Road Mitchelston Industrial Eastate
- City
- Dunfermline
- State
- Fife
- Postal Code
- KY13NL
- Country
- GB
- Correspondent
- Simon Revie
US Agent
- Business Name
- RAF SOLUTIONS USA, INC
- Contact Name
- Edwin Lindsay
- Address
- 10124 N.W. 53rd Street, Sunrise
- City
- Fort Lauderdale
- State
- FL
- ZIP
- 33351
- Country
- US
- [email protected]
- Phone
- 305 9607262
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2021-12-22 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2021-12-22 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2021-12-22 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2021-12-22 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2021-12-22 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2021-12-22 |
Proprietary Names
G2 Wearable Device
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)