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OrthoView

by Materialise NV

Ref OrthoView

OrthoView is a device classified as Class IIa in the EU and Class II in the US made by Materialise NV, registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI 54040280B1030VF) and listed in FDA GUDID since 22 May 2026 (UDI-DI 05404028007006), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number54040280B1030VF Basic UDI-DI 05404028007006UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05404028007006 UDI-DI Date22 May 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 54040280B1030VF registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI 05404028007006 listed 22 May 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05404028007006
  2. Registered EUDAMED 54040280B1030VF

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  • Withdrawn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

Generic name
Orthopaedic/craniofacial implantation planning software
Model / Ref / Catalog
OrthoView
Primary DI / UDI-DI
05404028007006
Basic UDI-DI
54040280B1030VF
FDA product code
LLZ
EMDN code
Z119092 Various bioimaging and radiotherapy instruments - medical device software
GMDN term
Orthopaedic/craniofacial implantation planning software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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

Similar devices in this category

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

Other devices from Materialise NV

See all devices from Materialise NV →

Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)