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suiteDXT Software

by NeoSoft LLC

Ref NS-02-050-0001

suiteDXT Software (NS-02-050-0001) is a Class I device made by Neosoft, LLC, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 0850001088suiteDXTNL), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0850001088suiteDXTNL Basic UDI-DI 00850001088022UDI-DIDate22 Oct 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
suiteDXT Software
Model / reference
NS-02-050-0001
Primary DI / UDI-DI
00850001088022
Basic UDI-DI
0850001088suiteDXTNL
EMDN code
Z11050182 Magnetic resonance (MR) systems - software accessories
Device class
Class I
Special device type
Software
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000007437
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

Other properties (14, all answered No)