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Incisive CT

by Philips Healthcare (Suzhou) Co., Ltd. 2 variants

Ref 728144

Incisive CT (728144) 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 26 Jun 2025 (Basic UDI-DI 0884838BM285T6) and listed in FDA GUDID since 30 Dec 2021 (UDI-DI 00884838105508), 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 Number0884838BM285T6 Basic UDI-DI 00884838105508UDI-DIDate26 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838105508 UDI-DI Date30 Dec 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0884838BM285T6 registered 26 Jun 2025 Active
  • FDA GUDID UDI-DI 00884838105508 listed 30 Dec 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00884838105508
  2. Registered EUDAMED 0884838BM285T6

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  • Withdrawn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 (Incisive CT/CT5300)
Model / Ref / Catalog
728144, Incisive CT
Primary DI / UDI-DI
00884838105508
Basic UDI-DI
0884838BM285T6
Direct marketing DI
00884838105508
FDA product code
JAK
EMDN code
Z11030606 Computed tomographs - 128 layers or more but less than 256 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
728144
GUDID
Incisive CT
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 - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS.

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

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

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)