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Arvis ® In-26100

by Kico Knee Innovation Company Pty Limited

Ref IN-26100

Arvis In-26100 is a medical device (EU MDR Class I; FDA Class II; FDA product code SBF, Orthopedic Augmented Reality; EMDN category orthopaedic surgery guides) made by Kico Knee Innovation Company Pty Limited, registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI 088891200000000L09220B4D9) and listed in FDA GUDID since 29 Jul 2025 (UDI-DI 00850012315919), 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 Number088891200000000L09220B4D9 Basic UDI-DI 00850012315919UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850012315919 UDI-DI Date29 Jul 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 088891200000000L09220B4D9 registered 20 Oct 2026 Active
  • FDA GUDID UDI-DI 00850012315919 listed 29 Jul 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850012315919
  2. Registered EUDAMED 088891200000000L09220B4D9

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  • Withdrawn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
Arvis ®
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
ARVIS Instruments - Rotation Guides
Model / reference
IN-26100
Primary DI / UDI-DI
00850012315919
Basic UDI-DI
088891200000000L09220B4D9
Direct marketing DI
00850012315919
FDA product code
SBF
EMDN code
L0922 Orthopaedic surgery guides, reusable
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
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.

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY GUIDES, REUSABLE.

Other devices from Kico Knee Innovation Company Pty Limited

See all devices from Kico Knee Innovation Company Pty Limited →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)