Arvis IN-14200: CE/MDR Class I

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number08889120000Z12011480S00KP Basic UDI-DI 00810180350730UDI-DI	Date2 Sep 2025Registered	StatusActive
United States	GUDID listing GUDID	Number00810180350730 UDI-DI	Date23 May 2025Listed	StatusListed GUDID: in commercial distribution

Official records

EUDAMED public site Basic UDI-DI 08889120000Z12011480S00KP — open Devices and search for it
AccessGUDID record UDI-DI 00810180350730

Across registries

2 registries list this device

EUDAMED Basic UDI-DI 08889120000Z12011480S00KP registered 2 Sep 2025 Active
FDA GUDID UDI-DI 00810180350730 listed 23 May 2025 Listed

Timeline

2 dated events

23 May 2025 Listed FDA GUDID 00810180350730
2 Sep 2025 Registered EUDAMED 08889120000Z12011480S00KP

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name: Orthopaedic prosthesis implantation positioning instrument, reusable
Device name: ARVIS Hip & Knee Instrument Set
Model / reference: IN-14200

Primary DI / UDI-DI: 00810180350730
Basic UDI-DI: 08889120000Z12011480S00KP
FDA product code: OLO
EMDN code: Z12011480 Surgical navigation instruments - hardware accessories
GMDN term: Orthopaedic prosthesis implantation positioning instrument, reusable

Device class: Class I EUDAMED
Class II GUDID
Regulation number: 882.4560
System or procedure pack: Procedure pack
EU registration type: System or procedure pack
Medical purpose: The ARVIS system is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated.
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class I	GUDID Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.