Skip to content

CT Areta RT

by Philips Healthcare (Suzhou) Co., Ltd.

Ref 728382

CT Areta RT (728382) is a device classified as Class IIb in the EU and Class II in the US made by Philips Healthcare (Suzhou) Co., Ltd., registered in EUDAMED on 12 Jul 2025 (Basic UDI-DI 0884838BM1701ME) and listed in FDA GUDID since 3 Apr 2026 (UDI-DI 00884838129542), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00884838129542 UDI-DI Date3 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0884838BM1701ME Basic UDI-DI 00884838129542UDI-DIDate12 Jul 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0884838BM1701ME registered 12 Jul 2025 Active
  • FDA GUDID UDI-DI 00884838129542 listed 3 Apr 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 0884838BM1701ME
  2. Listed FDA GUDID 00884838129542

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  • Withdrawn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
Full-body CT system
Device name
CT Scanner System (CT Rembra RT/CT Areta RT/CT Rembra)
Model / Ref / Catalog
728382, CT Areta RT
Primary DI / UDI-DI
00884838129542
Basic UDI-DI
0884838BM1701ME
FDA product code
JAK
EMDN code
Z11030605 Computed tomographs - 64 layers or more but less than 128 layers
GMDN term
Full-body CT system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1750
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
Model / referenceEUDAMED
728382
GUDID
CT Areta RT
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
CN-MF-000003923
Authorised representative
Philips Medical Systems Nederland B.V. NL-AR-000001422

Similar devices in this category

Other devices filed under COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS.

Other devices from Philips Healthcare (Suzhou) Co., Ltd.

See all devices from Philips Healthcare (Suzhou) Co., Ltd. →

Properties

  • Measuring function
  • Prescription use
  • Serial number
Other properties (22, all answered No)