# Spectrum Medical Ltd (manufacturer, GLOUCESTER Gloucestershire, GB): 3 new FDA device listings, incl. control, pump speed, cardiopulmonary bypass

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Spectrum Medical Ltd |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | GLOUCESTER Gloucestershire, GB |
| New listings | 3 |
| Devices | Control, Pump Speed, Cardiopulmonary Bypass; Console, Heart-Lung Machine, Cardiopulmonary Bypass; Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type |
| Product codes | DWA, DTQ, KFM |
| Device classes | Class II |
| Medical specialties | Cardiovascular |
| Brand names | Quantum Centrifugal Drive QCD37; Quantum Centrifugal Drive QCD22 |
| First new listing | 2026-09-09 |
| Latest new listing | 2026-09-09 |
| FDA registration number | 3006073153 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.