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ApolloHipX THR.SS.0001

by Corin Ltd

Ref THR.SS.0001Model ApolloHipX

ApolloHipX THR.SS.0001 is a robotic surgical system application software (EU MDR Class IIa; FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Corin Ltd, registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI 50553438APLHPXHM) and listed in FDA GUDID since 3 Jun 2025 (UDI-DI 05056139249501), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number50553438APLHPXHM Basic UDI-DI 05056139249501UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05056139249501 UDI-DI Date3 Jun 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 50553438APLHPXHM registered 16 Oct 2026 Active
  • FDA GUDID UDI-DI 05056139249501 listed 3 Jun 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05056139249501
  2. Registered EUDAMED 50553438APLHPXHM

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  • Withdrawn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
ApolloHipX
Generic name
Robotic surgical system application software
Model / reference
THR.SS.0001, ApolloHipX
Primary DI / UDI-DI
05056139249501
Basic UDI-DI
50553438APLHPXHM
FDA product code
LLZ
EMDN code
Z12139082 Various orthopaedic and traumatology instruments - software accessories
GMDN term
Robotic surgical system 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
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Robotic surgical system application software

Similar devices in this category

Other devices filed under VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS.

Other devices from Corin Ltd

See all devices from Corin Ltd →

Properties

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