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Zenition 50

by Philips Medical Systems Nederland B.V.

Ref 718096Model Zenition 50

Zenition 50 (718096) is a device classified as Class IIb in the EU and Class II in the US made by Philips Medical Systems Nederland B.V., registered in EUDAMED on 19 Jun 2023 (Basic UDI-DI 0884838BM349T7) and listed in FDA GUDID since 4 Apr 2019 (UDI-DI 00884838091535), 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 Number0884838BM349T7 Basic UDI-DI 00884838091535UDI-DIDate19 Jun 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838091535 UDI-DI Date4 Apr 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0884838BM349T7 registered 19 Jun 2023 Active
  • FDA GUDID UDI-DI 00884838091535 listed 4 Apr 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00884838091535
  2. Registered EUDAMED 0884838BM349T7

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  • Withdrawn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
Zenition 50 EUDAMED
Zenition GUDID
Generic name
Mobile general-purpose fluoroscopic x-ray system, digital
Model / Ref / Catalog
Zenition 50, 718096
Primary DI / UDI-DI
00884838091535
Basic UDI-DI
0884838BM349T7
FDA product code
OXO, JAA, OWB
EMDN code
Z11039017 Mobile radioscopic units
GMDN term
Mobile general-purpose fluoroscopic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1650
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Contains latexEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Contains latex UDI-DI 00884838091535: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIb 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: Mobile general-purpose fluoroscopic x-ray system, digital

Similar devices in this category

Other devices filed under MOBILE RADIOSCOPIC UNITS.

Other devices from Philips Medical Systems Nederland B.V.

See all devices from Philips Medical Systems Nederland B.V. →

Properties

  • Contains latex NoEUDAMEDYesGUDID
  • Measuring function
  • Prescription use
  • Serial number
Other properties (21, all answered No)