Spectrum Medical Ltd
United Kingdom (ex Northern Ireland) GB-MF-000033594 Last updated 23 Oct 2026
- Devices
- 28
- Registries
- EUDAMEDGUDIDFDA 510(k)FDA
- FDA recalls
- 64 ongoing
Catalogue
Quantum Centrifugal Emergency Hand Crank High Pressure Ref 52-000149-00
Quantum Light - SAP1 Ref 52-000140-00
Quantum Pump Frame 2 (v2) - Cheltenham (QPF2) Ref QPF9 - part no. 51-000163-00
Quantum Informatics - Viper Ref VIPER
Quantum Pump Frame 2 (v2) - Cheltenham (QPF2) Ref QPF8 - part no. 51-000162-00
Quantum Mini Pump Drive Module Ref 51-000160-00
Hand Crank Assembly - 4 inch Ref 43-000956-00
Hose Kit - 12.5 mm Bore - 2.5 m long Ref 52-000055-00
Hand Crank Assembly - 4 inch Ref 43-000954-00
Hose Kit - 12.5 mm Bore - 2.5 m long Ref 52-000056-00
Hand Crank Assembly - 4 inch Ref 43-000955-00
Quantum Light - SAP1 Ref 52-000141-00
M3 Monitor Ref K072131
Quantum Heater-Cooler Ref K212657
Quantum Workstation Ref K163657
Quantum Workstation 12 Elite Ref K202557
M2 Monitor Ref K071725
Quantum Mini Ventilation Module Ref K210669
Quantum Ventilation Module Ref K181942
Quantum Workstation 12.1 Ref K181923
M3 Monitor Ref K091908
Quantum Ventilation Module Ref K202733
Quantum Pump Console Ref K173834
Quantum Informatics - Vision / Live Vue Ref VISION/LIVE VUE
EUDAMED certificates
TUV Rheinland Italia SRL 1936 1 certificate
- ITH 2648948 1 Issued
Quality management system EU MDR
- Issued
- 28 Apr 2026
- Expires
- 27 Apr 2031
Related companies
Authorised representatives
Notified bodies
FDA recalls
2026
- 17 Jul 2026 Z-3327-2026 Class II Ongoing Due to blood-to-glycol leak in the heat exchanger.
- 17 Jul 2026 Z-3328-2026 Class II Ongoing Due to blood-to-glycol leak in the heat exchanger.
2025
- 19 Mar 2025 Z-1695-2025 Class II Ongoing Medical device software marketed without FDA clearance .
- 19 Mar 2025 Z-1696-2025 Class II Ongoing Medical device software marketed without FDA clearance .
2023
- 13 Mar 2023 Z-0224-2025 Class II Completed The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
2019
- 29 May 2019 Z-2238-2019 Class I Terminated Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.
Information
- Country
- United Kingdom (ex Northern Ireland)
- Address
- Ashville Business Park, Commerce Road, Gloucester, United Kingdom (ex Northern Ireland)
- Website
- www.spectrummedical.com
- [email protected]
- Phone
- +44 (0) 1242 650120
- PRRC contact
- Mark Drain
- EUDAMED SRN
- GB-MF-000033594
- FDA FEI number
- 3006073153