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ECTphan™

by Phantom Laboratory 4 variants

Ref SMR355

ECTphan (SMR355) is a medical device (EU MDD Class I; EMDN category various bioimaging and radiotherapy instruments - hardware accessories) made by Phantom Laboratory, registered in EUDAMED on 3 Jan 2023 (Basic UDI-DI B-SMR355JP), active as of 25 Oct 2026.

Active European Union

CE MDD

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-SMR355JP Basic UDI-DI D-SMR355JPUDI-DIDate3 Jan 2023RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device name
SMR355
Model / reference
SMR355
Primary DI / UDI-DI
D-SMR355JP
Basic UDI-DI
B-SMR355JP
EMDN code
Z119080 Various bioimaging and radiotherapy instruments - hardware accessories
Device class
Class I
EU registration type
Legacy device (under a directive)
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
US-MF-000027490
Authorised representative
Hoff & Lowendahl AB SE-AR-000001888

Similar devices in this category

Other devices filed under VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Phantom Laboratory

See all devices from Phantom Laboratory →

Properties

Other properties (12, all answered No)