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icometrix NV

Active in EUDAMED

Registered as icometrix in EUDAMED

Belgiumfrom SRN EUDAMED SRN BE-MF-000006329

Part of icometrix

icometrix NV is a medical device manufacturer based in Belgium, with 27 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class IIa) as of 15 Nov 2026.

Devices
27
Registrations
EUDAMED

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • FDA GUDID 17
  • EUDAMED 7
  • FDA 510(k) 3

A device listed in two registries counts in both.

Device classes
  • FDA Class II 17
  • EU Class IIa 7
  • FDA Class I 3
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN BE-MF-000006329
  • DUNS 400793486

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

Catalogue27

Newest first, rows 1-27 of 27

Search and filter all 27 devices
Skip device list

  • icobrain ctp 1.7

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

  • icobrain aria 1.2

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

  • icompanion 1

    Listed Registry: GUDID Class:I

  • icobrain ct 6.4

    Listed Registry: GUDID Class:II

  • icobrain 6

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

  • icobrain mr 5.17

    Listed Registry: GUDID Class:II

  • icobrain 4.0

    Listed Registry: GUDID Class:II

  • icobrain mr 5.14

    Listed Registry: GUDID Class:II

  • icobrain ctp 1

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

  • icompanion 2.2

    Listed Registry: GUDID Class:I

  • icobrain mr 5.15

    Listed Registry: GUDID Class:II

  • icobrain 3

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

  • icompanion 2.1

    Active Regimes: CE MDR Registry: GUDID Class:I

  • icobrain aria 1.1

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

  • icobrain 5

    Listed Registry: GUDID Class:II

  • icobrain 2

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

  • icobrain mr 5.16

    Active Regimes: CE MDR Registry: GUDID Class:II

  • icobrain mr Ref 5.16.z

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • icobrain aria Ref K240712

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

  • Icobrain Ref K192130

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

  • icobrain Ref K181939

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

  • icobrain mr Ref 5.15.z

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • icobrain ct Ref 6.4.z

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • icompanion Ref 2.2.z

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • icobrain mr Ref 6.16.z

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • icobrain ctp Ref 1.7.z

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • icobrain mr Ref 5.17.z

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

Rows 1-27 of 27

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
BE-MF-000006329
DUNS number
400793486
EU VAT number
BE0833377379
EUDAMED status
Active
EUDAMED registered name
icometrix
Registered address
1B, Kolonel Begaultlaan, 3012, Leuven, Belgium
Phone
+3216369000
PRRC contact
Alicia Legrand(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 11 Dec 2028

EUDAMED certificates (1)

SGS Belgium NV 1639 1 certificate

  • BE23/00000345 Active Supplemented

    Quality management system EU MDR

    Issued
    11 Dec 2023
    Expires
    11 Dec 2028
    Reason
    Change approved

Frequently asked questions

How many devices does icometrix NV have in the registry?

The registry currently lists 27 devices for icometrix NV. Devices recorded under merged duplicate company entries are counted once.

Which registries list icometrix NV's devices?

Among its 27 most recently registered devices, icometrix NV has devices listed in EUDAMED (7 devices), FDA 510(k) (3 devices) and FDA GUDID (17 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do icometrix NV's devices fall under?

Among its 27 most recently registered devices, the classes recorded for icometrix NV's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for icometrix NV?

EUDAMED lists 1 certificate for icometrix NV (quality management system) under MDR. The most recent was issued on 11 Dec 2023.

What are the newest devices from icometrix NV in the registry?

The most recently registered devices listed for icometrix NV include icobrain ctp 1.7, icobrain aria 1.2, icompanion 1 and icobrain ct 6.4.

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