FDA Registration
Active
🇬🇧 United Kingdom
SPECTRUM MEDICAL LTD
Reg #: 3006073153
·
FEI: 3006073153
·
Expires 2026
Products
8
Proprietary Names
28
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- SPECTRUM MEDICAL LTD
- Registration Number
- 3006073153
- FEI Number
- 3006073153
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Ashville Business Park, Commerce Road
- City
- GLOUCESTER Gloucestershire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K202557
Owner / Operator
- Firm Name
- SPECTRUM MEDICAL LTD
- Operator Number
- 9094087
- Address
- Ashville Business Park, Commerce Road
- City
- Gloucester
- State
- Gloucestershire
- Postal Code
- GL2 9SL
- Country
- GB
- Correspondent
- Asia Lukuc
US Agent
- Business Name
- Spectrum Medical Inc.
- Contact Name
- Cameron Schmitt
- Address
- 481 Munn Road, Suite 180
- City
- Fort Mills
- State
- SC
- ZIP
- 29715
- Country
- US
- [email protected]
- Phone
- 803 8333964
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | DRY | Class 2 | Cardiovascular | No | 2022-03-18 |
| Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | KFM | Class 2 | Cardiovascular | No | 2020-04-14 |
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | Class 2 | Cardiovascular | No | 2025-09-12 |
| Controller, Temperature, Cardiopulmonary Bypass | DWC | Class 2 | Cardiovascular | No | 2022-05-10 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2011-04-04 |
| Console, Heart-Lung Machine, Cardiopulmonary Bypass | DTQ | Class 2 | Cardiovascular | No | 2019-05-28 |
| Gas Control Unit, Cardiopulmonary Bypass | DTX | Class 2 | Cardiovascular | No | 2021-05-05 |
| Accessory Equipment, Cardiopulmonary Bypass | KRI | Class 1 | Cardiovascular | No | 2023-06-15 |
Proprietary Names
Quantum Elite 12" Workstation
Quantum Elite 12
Quantum Centrifugal Drive QCD-37
Quantum Centrifugal Drive QCD-22
Quantum Micro-Cardioplegia Delivery Module
Quantum Diagnostic Module 2
Quantum Diagnostic Module 1
SPECTRUM M2 MONITOR
SPECTRUM M2 - M System
Quantum Workstation
VIPER
M4
SPECTRUM M4
Quantum Smart Occluder Right
Quantum Smart Occluder Left
Quantum Workstation 12.1"
Quantum Workstation 12.1 inch
Quantum Mini Ventilation Module
Quantum Pump Console
Quantum Ventilation Module
Quantum Pump Frame 4 - New York
Quantum Pump Frame 8 - Mini Frame
Quantum Reservoir Level Sensor Cradle
Quantum Light - SAP Type 1
Quantum Pump Frame 5 - Charlotte
Quantum Pump Frame 9 - Mirandola
Quantum Pump Frame 2 - Cheltenham
Quantum Light - SAP Type 3
Establishment Types
Manufacture Medical Device