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DigitalDiagnost 4 High Performance

by Philips Medical Systems DMC GmbH

Part of a family of 7 devices: see the family page

Ref 712031

DigitalDiagnost 4 High Performance (712031) is a device classified as Class IIb in the EU and Class II in the US made by Philips Medical Systems DMC GmbH, registered in EUDAMED on 12 Jun 2024 (Basic UDI-DI 0884838BM440SS) and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00884838065321), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884838BM440SS Basic UDI-DI 00884838065321UDI-DIDate12 Jun 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838065321 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0884838BM440SS registered 12 Jun 2024 Active
  • FDA GUDID UDI-DI 00884838065321 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00884838065321
  2. Registered EUDAMED 0884838BM440SS

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  • Withdrawn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
DigitalDiagnost 4 High Performance EUDAMED
DigitalDiagnost GUDID
Generic name
Stationary basic diagnostic x-ray system, digital
Device name
Fixed Rad-System
Model / Ref / Catalog
712031
Primary DI / UDI-DI
00884838065321
Basic UDI-DI
0884838BM440SS
FDA product code
MQB, KPR, LLZ
EMDN code
Z11039099 Various radiodiagnostic and interventional instruments – other
GMDN term
Stationary basic diagnostic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1680, 892.2050
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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.

Manufacturer details

EUDAMED SRN
DE-MF-000005362

Related devices

Category: Electromagnetic surgical navigation device tracking system

Similar devices in this category

Other devices filed under VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER.

Other devices from Philips Medical Systems DMC GmbH

See all devices from Philips Medical Systems DMC GmbH →

Properties

  • Prescription use
  • Combination product
  • Serial number
Other properties (22, all answered No)