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HiRise

by CurveBeam LLC

Ref 1040

HiRise (1040) is a device classified as Class IIb in the EU and Class II in the US made by CurveBeam LLC, registered in EUDAMED on 20 Oct 2021 (Basic UDI-DI 8631520003CBCTDevicesCL) with CE/MDR certificate 28620146078-02 valid until 20 Jun 2027, cleared under FDA 510(k) K203187 on 18 Nov 2020 and listed in FDA GUDID since 20 Jan 2021 (UDI-DI 00860004550037), expiring (EUDAMED), active (FDA 510(k)) as of 24 Oct 2026.

Expiring Expiring in European Union. Active in United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

20 Jun 2027

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

510(k) K203187↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number28620146078-02 Date10 Feb 2025IssuedStatusExpiring expires 20 Jun 2027
United StatesGUDID listing GUDID Number00860004550037 UDI-DI Date20 Jan 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK203187 Date18 Nov 2020IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8631520003CBCTDevicesCL registered 20 Oct 2021 Active· +1 more in the status table
  • FDA 510(k) K203187 decided 18 Nov 2020 Active
  • FDA GUDID UDI-DI 00860004550037 listed 20 Jan 2021 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 28620146078-02 Expiring Expires in 218 days

    Quality management system EU MDR

    Certifier
    Intertek Medical Notified Body AB 2862
    Issued
    10 Feb 2025
    Expires
    20 Jun 2027

Timeline

5 dated events

  1. Cleared FDA 510(k) K203187
  2. Listed FDA GUDID 00860004550037
  3. Registered EUDAMED 8631520003CBCTDevicesCL
  4. Certificate issued EUDAMED 28620146078-02
  5. Certificate expires EUDAMED 28620146078-02

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic name
Limited-view-field CT system
Model / reference
1040 EUDAMED
1040-230 GUDID
Primary DI / UDI-DI
00860004550037
Basic UDI-DI
8631520003CBCTDevicesCL
Direct marketing DI
00860004550037
510(k) Number
FDA product code
JAK
EMDN code
Z11030699 Computed tomographs (CT) - other
GMDN term
Limited-view-field CT system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1750
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1040
GUDID
1040-230
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
US-MF-000004033
Authorised representative
ea-services FR-AR-000003449

Similar devices in this category

Other devices filed under COMPUTED TOMOGRAPHS (CT) - OTHER.

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)