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HipCheck 01030300

by Stryker Corp.

Ref 0103-0300Model 08858251003421SM

HipCheck 01030300 (0103-0300) is a device classified as Class IIa in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 08858251003421SM), cleared under FDA 510(k) K182359 on 13 Dec 2018 and listed in FDA GUDID since 23 Jan 2019 (UDI-DI 07613327459081), active as of 7 Nov 2026.

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

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182359

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251003421SM Basic UDI-DI 07613327459081UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327459081 UDI-DI Date23 Jan 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182359 Date13 Dec 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251003421SM registered 3 Nov 2026 Active
  • FDA 510(k) K182359 decided 13 Dec 2018 Active
  • FDA GUDID UDI-DI 07613327459081 listed 23 Jan 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K182359
  2. Listed FDA GUDID 07613327459081
  3. Registered EUDAMED 08858251003421SM

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
HipCheck
Generic name
Radiology DICOM image processing application software
Device name
SMBU_TF10449_HipCheck Software
Model / Ref / Catalog
08858251003421SM, 0103-0300, 01030300
Primary DI / UDI-DI
07613327459081
Basic UDI-DI
08858251003421SM
Direct marketing DI
07613327459081
510(k) Number
FDA product code
QIH
EMDN code
Z119082 Various bioimaging and radiotherapy instruments - software accessories
GMDN term
Radiology DICOM image processing application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251003421SM
0103-0300
GUDID
01030300
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Radiology DICOM image processing application software

Similar devices in this category

Other devices filed under VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - SOFTWARE ACCESSORIES.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)