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[ARVIS] Headband

by Kico Knee Innovation Company Pty Ltd

Ref IN-17100

[ARVIS] Headband (IN-17100) is a device classified as Class I in the EU and Class II in the US made by Kico Knee Innovation Company Pty Limited, registered in EUDAMED on 2 Sep 2025 (Basic UDI-DI 08889120000Z120114800D0G6) and listed in FDA GUDID since 23 May 2025 (UDI-DI 00810180350471), 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 Number08889120000Z120114800D0G6 Basic UDI-DI 00810180350471UDI-DIDate2 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00810180350471 UDI-DI Date23 May 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08889120000Z120114800D0G6 registered 2 Sep 2025 Active
  • FDA GUDID UDI-DI 00810180350471 listed 23 May 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810180350471
  2. Registered EUDAMED 08889120000Z120114800D0G6

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  • Withdrawn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 stereotactic surgery system
Model / reference
IN-17100
Primary DI / UDI-DI
00810180350471
Basic UDI-DI
08889120000Z120114800D0G6
Direct marketing DI
00810180350471
FDA product code
OLO
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Orthopaedic stereotactic surgery system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

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.

Manufacturer details

EUDAMED SRN
AU-MF-000011477
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Related devices

Category: Neurological stereotactic surgery system

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

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Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)