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Delta4 Phantom+ PMMA

by Scandidos AB

Ref SDOS101-20Model Delta4 Phantom+

Delta4 Phantom+ PMMA (SDOS101-20) is a multi-modality therapeutic radiation phantom (EU MDR Class I; FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Scandidos AB, registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI 73500051800002EG) and listed in FDA GUDID since 25 Sep 2016 (UDI-DI 17350005180000), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number73500051800002EG Basic UDI-DI 17350005180000UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number17350005180000 UDI-DI Date25 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 73500051800002EG registered 5 Oct 2026 Active
  • FDA GUDID UDI-DI 17350005180000 listed 25 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 17350005180000
  2. Registered EUDAMED 73500051800002EG

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Delta4 Phantom+
Generic name
Multi-modality therapeutic radiation phantom, anthropomorphic
Model / Ref / Catalog
Delta4 Phantom+, SDOS101-20, PMMA
Primary DI / UDI-DI
17350005180000
Basic UDI-DI
73500051800002EG
Direct marketing DI
17350005180000
FDA product code
IYE
EMDN code
Z11019099 Various radiotherapy and radiosurgery instruments - other
GMDN term
Multi-modality therapeutic radiation phantom, anthropomorphic
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Delta4 Phantom+
SDOS101-20
GUDID
PMMA
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Multi-modality therapeutic radiation phantom, anthropomorphic

Similar devices in this category

Other devices filed under VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER.

Other devices from Scandidos AB

See all devices from Scandidos AB →

Properties

  • Measuring function
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)