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ART.1

by SeeTreat Pty Ltd

Model ART.1

ART.1 is a medical device (EU MDR Class IIa) made by SeeTreat Pty Ltd, registered in EUDAMED on 2 Dec 2025 (Basic UDI-DI 93616590DoseReviewV5) with CE/MDR certificate 1000235711 valid until 28 Oct 2030, active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

28 Oct 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number93616590DoseReviewV5 Basic UDI-DI 09361659000003UDI-DIDate2 Dec 2025RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000235711 Active

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    29 Oct 2025
    Expires
    28 Oct 2030

Timeline

3 dated events

  1. Certificate issued EUDAMED 1000235711
  2. Registered EUDAMED 93616590DoseReviewV5
  3. Certificate expires EUDAMED 1000235711

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
ART.1
Model / reference
ART.1
Primary DI / UDI-DI
09361659000003
Basic UDI-DI
93616590DoseReviewV5
EMDN code
Z119092 Various bioimaging and radiotherapy instruments - medical device software
Device class
Class IIa
Special device type
Software
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
AU-MF-000045001
Authorised representative
Qualrep Services B.V. NL-AR-000000537

Similar devices in this category

Other devices filed under VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from SeeTreat Pty Ltd

  • ART.1-Us

    Class II

Properties

Other properties (14, all answered No)