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Sign in to claim this brandSPECTRUM MEDICAL LIMITED
US
Last updated May 24, 2026
What SPECTRUM MEDICAL LIMITED makes
Spectrum Medical Limited manufactures components and systems for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) procedures. Their portfolio includes air bubble and fluid level detectors, blood gas/pH monitors, single-use heat exchangers, membrane oxygenators, gas control units, roller pumps, drainage cannulae, and centrifugal pumps. The Quantum series is central to their offerings, with variations tailored for specific clinical applications.
The company’s devices are classified under FDA regulations as Class I and Class II, with relevant products listed in the FDA’s Unique Device Identifier (UDI) database. Spectrum Medical Limited is based in the United States, adhering to applicable regulatory standards for medical devices in that jurisdiction.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Spectrum Medical Limited manufacture?
Spectrum Medical Limited specializes in devices used for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) procedures. Their portfolio includes critical components like air bubble and fluid level detectors, blood gas/pH monitors, single-use heat exchangers, membrane oxygenators, gas control units, roller pumps, drainage cannulae, and centrifugal pumps. These devices support life-saving interventions by ensuring precise control of blood flow, oxygenation, and temperature during surgery or critical care.
Where is Spectrum Medical Limited based, and does that affect the regulatory standards they follow?
Spectrum Medical Limited is based in the United States. As a U.S.-based manufacturer, their devices must comply with FDA regulations, including classification under Class I or Class II. This classification determines the level of scrutiny and regulatory requirements for each device type, ensuring safety and performance standards are met before market entry.
Which regulatory registries or databases list Spectrum Medical Limited’s devices?
Spectrum Medical Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system provides a standardized way to identify medical devices, ensuring transparency and traceability for healthcare providers, regulators, and patients. This listing helps streamline tracking and compliance with U.S. regulatory requirements.
How are Spectrum Medical Limited’s devices classified under FDA regulations?
Spectrum Medical Limited’s devices are classified under the FDA’s regulatory framework as either Class I or Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require additional performance standards or special controls. The classification ensures appropriate oversight based on the device’s intended use and potential risk to patients.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- spectrummedical.com
- —
- —
- [email protected]
- Phone
- +441242650120
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 516398679
Catalogue (226)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| System M ® | M2 | FDA UDI | Class II | Unknown |
| Quantum ® System M ® | HBS4-130 | FDA UDI | Class II | Active |
| Quantum SuperPAC Cardioplegia Tubing Set 1/4 | CGSP7-B0 | FDA UDI | Class II | Unknown |
| Quantum | 52-000027-00 | EUDAMEDFDA UDI | Class II | Active |
| Quantum SuperPAC Tubing set - SP09C-DA | SP09C-DA | FDA UDI | Class II | Active |
| Quantum | QFS5-RA-075 | FDA UDI | Class II | Active |
| Quantum SuperPAC Tubing Set - SP02V-BB | SP02V-BB | FDA UDI | Class II | Unknown |
| Quantum | QFS1-ST-200 | FDA UDI | Class II | Active |
| Quantum | QPF5 | FDA UDI | Class II | Active |
| Quantum | QVM3-D | FDA UDI | Class II | Active |
| Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors | CP22V-NG | FDA UDI | Class II | Active |
| Quantum PureFlow Standard Heat Exchanger Low Flow 3/8 | HX11W-S2 | FDA UDI | Class II | Active |
| Quantum SuperPAC Tubing Set - SP02C-AB | SP02C-AB | FDA UDI | Class II | Unknown |
| System M ® | Gas Module | FDA UDI | Class II | Unknown |
| Quantum ® System M ® | HBS2-200 | FDA UDI | Class II | Active |
| Quantum Perfusion Arterial Cannula Graft | AG08-V0 | FDA UDI | Class II | Active |
| Quantum SuperPAC Tubing Set - SP01C-DA | SP01C-DA | FDA UDI | Class II | Active |
| Quantum ® System M ® | HBS1-200 | FDA UDI | Class II | Active |
| Quantum PureFlow KIT CPC - Barbed Connector Adaptor | CONN-HX1 | FDA UDI | Class I | Active |
| Quantum SuperPAC Tubing set - SP09C-AA | SP09C-AA | FDA UDI | Class II | Active |
| KIT Quantum SuperPAC Tubing Set - 200R | SPC-200R | FDA UDI | Class II | Active |
| Quantum PureFlow Standard Heat Exchanger Low Flow 1/4 | HX11W-S1 | FDA UDI | Class II | Active |
| Quantum SuperPAC Hybrid CPB | SPC200A-D5 | FDA UDI | N/A | Active |
| System M ® | Hct / SO2 Sensor | FDA UDI | Class II | Active |
| Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 1/4 - PL | HX22W-C5 | FDA UDI | Class II | Active |
| Quantum ® System M ® | HBS1-130 | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Spectrum Medical Ltd GLOUCESTER Gloucestershire · GB FEI 3006073153