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302015025

by Medos International Sàrl

Ref 302015025Model UNAS Universal Navigation Adaptor Set Array

302015025 is a device classified as Class I in the EU and Class II in the US made by Medos International Sàrl, registered in EUDAMED on 24 Dec 2025 (Basic UDI-DI 0705034a000135D), cleared under FDA 510(k) K241893 on 16 Sep 2024 (3 earlier submissions) and listed in FDA GUDID since 15 Apr 2021 (UDI-DI 10705034536194), active as of 23 Oct 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241893

+3 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a000135D Basic UDI-DI 10705034536194UDI-DIDate24 Dec 2025RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK241893 Date16 Sep 2024DecidedStatusActive
United StatesGUDID listing GUDID Number10705034536194 UDI-DI Date15 Apr 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0705034a000135D registered 24 Dec 2025 Active
  • FDA 510(k) K241893 decided 16 Sep 2024 Active· +3 more in the status table
  • FDA GUDID UDI-DI 10705034536194 listed 15 Apr 2021 Listed

Timeline

6 dated events

  1. Cleared FDA 510(k) K201661
  2. Listed FDA GUDID 10705034536194
  3. Cleared FDA 510(k) K212756
  4. Cleared FDA 510(k) K223108
  5. Cleared FDA 510(k) K241893
  6. Registered EUDAMED 0705034a000135D

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  • Withdrawn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
Universal Navigation Adaptor Set
Generic name
Optical surgical tracking system spatial marker, reusable
Device name
UNAS Universal Navigation Adaptor Set Navigation Array
Model / Ref / Catalog
302015025, UNAS Universal Navigation Adaptor Set Array
Primary DI / UDI-DI
10705034536194
Basic UDI-DI
0705034a000135D
Direct marketing DI
10705034536194
510(k) Number
FDA product code
OLO
EMDN code
Z12130480 Stereotactic orthopaedic surgery instruments - hardware accessories
GMDN term
Optical surgical tracking system spatial marker, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Belgium
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

Cleared under the same submission (K212756)

and 5 more cleared under K212756

Cleared under the same submission (K223108)

Similar devices in this category

Other devices filed under STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

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