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Spectrum Medical SRL

Active in EUDAMED

Italyfrom SRN EUDAMED FDA SRN IT-MF-000009234 FEI 3016746283

Devices
20
Registrations
EUDAMEDFDA
FDA recalls
11 ongoing

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI, FDA recalls

What Spectrum Medical SRL makes

Spectrum Medical SRL manufactures medical devices including the Quantum SuperPac, Quantum Perfusion Hybrid Reservoir, Quantum Perfusion, and Quantum PureFlow, which are perfusion systems and related components.

The company's devices are classified as Class I and Class IIa and are listed in the EUDAMED database. Spectrum Medical SRL is based in Italy.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue20

Newest first, rows 1-20 of 20

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  • Quantum PureFlow Ref HX11W-S1L

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Quantum SuperPAC Ref SPE200F-B2

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Quantum SuperPac Ref SPE075C-C2

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Quantum SuperPAC Ref SPE075F-C1

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Quantum Perfusion Ref CP37V-V0

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Quantum PureFlow Ref HX11W-S2L

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Quantum SuperPAC Ref SPCCPGD-D4

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Quantum SuperPAC Ref SPC160A-D4

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Quantum PureFlow Ref HX11V-S0W

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Quantum SuperPAC Ref SPC160A-D5

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Quantum SuperPAC Ref SPE200C-B2

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Quantum SuperPac Ref SPE075C-C1

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Quantum PureFlow Ref CONN-HX1

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Quantum PureFlow Ref HX22V-S0W

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Quantum SuperPac Ref CGSP8-B0

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Quantum Perfusion Hybrid Reservoir Ref HR04V-A0

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Quantum SuperPac Ref SPCCPGD-D1

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Quantum Perfusion Ref CP22V-VPL

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Quantum PureFlow Ref HX32V-C0W

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Quantum PureFlow Ref CONN-HX2

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

Rows 1-20 of 20

Company details

EUDAMED SRN
IT-MF-000009234
FDA FEI number
3016746283
DUNS number
436188505
EU VAT number
IT03663360364
EUDAMED status
Active
EUDAMED registered name
SPECTRUM MEDICAL SRL
Registered address
23, via di Mezzo, 41037, Mirandola, Italy
PRRC contact
Raffaella Tommasini(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 8 Apr 2028

EUDAMED certificates (1)

TUV Rheinland Italia SRL 1936 1 certificate

  • ITD 1344656 1 Active Supplemented

    Quality assurance EU MDR

    Issued
    22 Sep 2026
    Expires
    8 Apr 2028
    Reason
    Other

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by SPECTRUM MEDICAL SRL, initiated on 2025-01-16. By recorded status: 1 ongoing. The reasons filed fall into these groups: labeling or instructions for use and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 1
  • 2026 0

  • 2025

    • 16 Jan 2025 Z-1327-2025 Class II Ongoing Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures. Distribution: US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Colorado, Connecticut,…
      Full distribution text US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, and Washington.
      Submission number: K201320

Frequently asked questions

How many devices does SPECTRUM MEDICAL SRL have in the registry?

The registry currently lists 20 devices for SPECTRUM MEDICAL SRL. Devices recorded under merged duplicate company entries are counted once.

Which registries list SPECTRUM MEDICAL SRL's devices?

Among its 20 most recently registered devices, SPECTRUM MEDICAL SRL has devices listed in EUDAMED (20 devices) and FDA GUDID (11 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do SPECTRUM MEDICAL SRL's devices fall under?

Among its 20 most recently registered devices, the classes recorded for SPECTRUM MEDICAL SRL's devices are Class I and Class IIa. Each device page shows its own class and authorisation.

Are there FDA recall records for SPECTRUM MEDICAL SRL?

FDA recall records list 1 recall initiated by SPECTRUM MEDICAL SRL, the most recent initiated on 16 Jan 2025. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for SPECTRUM MEDICAL SRL?

EUDAMED lists 1 certificate for SPECTRUM MEDICAL SRL (quality assurance) under MDR. The most recent was issued on 22 Sep 2026.

What are the newest devices from SPECTRUM MEDICAL SRL in the registry?

The most recently registered devices listed for SPECTRUM MEDICAL SRL include Quantum PureFlow, Quantum SuperPAC, Quantum Perfusion and Quantum Perfusion Hybrid Reservoir.

Generated automatically from registry data and not verified by a human reviewer.