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Perspectum, Ltd.

Active in EUDAMED

United Kingdomfrom SRN EUDAMED FDA SRN GB-MF-000016685

Perspectum, Ltd. is a medical device manufacturer based in the United Kingdom, with 5 devices listed in FDA 510(k), EUDAMED and FDA GUDID (FDA Class II; EU Class I, IIa and IIb) as of 13 Nov 2026.

Devices
5
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA 510(k) 5
  • EUDAMED 4
  • FDA GUDID 1

A device listed in two registries counts in both.

Device classes
  • FDA Class II 2
  • EU Class I 1
  • EU Class IIa 1
  • EU Class IIb 1
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN GB-MF-000016685
  • DUNS 218593632

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 2 in force.

See certificates

Market reach

European Union
EUDAMED actor, 2 certificates
United States
FDA establishment
Authorised rep.
Perspectum Unipessoal LdaPT

What Perspectum, Ltd. makes

Perspectum, Ltd. develops magnetic resonance imaging (MRI) software solutions for liver and abdominal imaging, including tools for automated liver segmentation, lesion detection, and quantitative analysis. Their products include CoverScan for liver coverage planning, VitruvianScan for dynamic contrast-enhanced MRI analysis, and MRCP+ for magnetic resonance cholangiopancreatography. Hepatica and LiverMultiScan provide specialized imaging and analysis for liver disease assessment and monitoring.

The company’s devices are classified under EU Medical Device Regulations as Class I, Class II, Class IIa, and Class IIb, with corresponding listings in the EUDAMED database and FDA’s 510(k) registry. Perspectum, Ltd. is based in the United Kingdom and adheres to relevant regulatory frameworks for software-as-a-medical-device (SaMD) applications in imaging diagnostics.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue5

Newest first, rows 1-5 of 5

  • CoverScan v1 Ref K212565

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • VitruvianScan (v1.0) Ref K241925

    Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k) Class:II

  • Mrcp+ Ref 1.01

    Active Regimes: CE MDD 510(k) Registry: EUDAMED510(k) Class:I

  • Hepatica Ref v1

    Active Regimes: 510(k) CE MDR, withdrawn Registry: EUDAMED510(k) Class:IIb

  • LiverMultiScan

    Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:IIa

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
GB-MF-000016685
DUNS number
218593632
EU VAT number
171 9358 85
EUDAMED status
Active
EUDAMED registered name
Perspectum Ltd
Registered address
Gemini One, 5520 John Smith Drive, OX4 2LL, Oxford, United Kingdom (ex Northern Ireland)
Phone
+44 01865 655343
PRRC contact
Bhaskar Chikkanna(public in EUDAMED)

EUDAMED certificates2

2 certificates1 valid, 0 expired, 1 withdrawn or suspendedMDR 2next expiry 21 May 2029

EUDAMED certificates (2)

BSI Group The Netherlands B.V. 2797 1 certificate

  • MDR 735482 Withdrawn

    Quality management system EU MDR

    Issued
    7 Feb 2026
    Expires
    21 May 2029
    Reason
    Transferred to other nb

Scarlet NB B.V. 3022 1 certificate

  • SCAR-22.2.1.1 Restricted

    Quality management system EU MDR

    Issued
    28 Jul 2026
    Expires
    21 May 2029
    Reason
    Not on market

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Perspectum GB

Frequently asked questions

How many devices does Perspectum, Ltd. have in the registry?

The registry currently lists 5 devices for Perspectum, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Perspectum, Ltd.'s devices?

Among its 5 most recently registered devices, Perspectum, Ltd. has devices listed in EUDAMED (4 devices), FDA 510(k) (5 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Perspectum, Ltd.'s devices fall under?

Among its 5 most recently registered devices, the classes recorded for Perspectum, Ltd.'s devices are Class I, Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Perspectum, Ltd.?

EUDAMED lists 2 certificates for Perspectum, Ltd. (quality management system) under MDR. The most recent was issued on 28 Jul 2026.

What are the newest devices from Perspectum, Ltd. in the registry?

The most recently registered devices listed for Perspectum, Ltd. include CoverScan v1, VitruvianScan (v1.0), MRCP+ and Hepatica.

Which FDA establishments are linked to Perspectum, Ltd.?

1 FDA establishment is linked to Perspectum, Ltd. in the registry; they are listed on the company page.

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