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Ion 490105

by Intuitive Surgical, Inc.

Ref 490105

Ion 490105 is a bronchoscopic catheter (EU MDR Class IIa; FDA Class II; FDA product code EOQ, Bronchoscope (flexible or rigid)) made by Intuitive Surgical, Inc., registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 08868741211157F) and listed in FDA GUDID since 30 May 2019 (UDI-DI 00886874116258), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08868741211157F Basic UDI-DI 00886874116258UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874116258 UDI-DI Date30 May 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08868741211157F registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 00886874116258 listed 30 May 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874116258
  2. Registered EUDAMED 08868741211157F

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  • Withdrawn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
Fully Articulating Catheter EUDAMED
Ion GUDID
Generic name
Bronchoscopic catheter
Device name
Ion Articulating Catheter
Model / reference
490105
Primary DI / UDI-DI
00886874116258
Basic UDI-DI
08868741211157F
Direct marketing DI
00886874116258
FDA product code
EOQ
EMDN code
Z12020801 Bronchoscopes
GMDN term
Bronchoscopic catheter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.4680
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 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: Bronchoscopic catheter

Similar devices in this category

Other devices filed under BRONCHOSCOPES.

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)