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Ion 380748

by Intuitive Surgical, Inc.

Ref 380748

Ion 380748 is a surgical planning/navigation-enhancement system (EU MDR Class IIa; FDA Class II; FDA product code EOQ, Bronchoscope (flexible or rigid)) made by Intuitive Surgical, Inc., registered in EUDAMED on 28 Aug 2026 (Basic UDI-DI 08868741211087J) and listed in FDA GUDID since 21 Mar 2019 (UDI-DI 00886874116234), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08868741211087J Basic UDI-DI 00886874116234UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874116234 UDI-DI Date21 Mar 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08868741211087J registered 28 Aug 2026 Active
  • FDA GUDID UDI-DI 00886874116234 listed 21 Mar 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874116234
  2. Registered EUDAMED 08868741211087J

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  • Withdrawn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
System Cart EUDAMED
Ion GUDID
Generic name
Surgical planning/navigation-enhancement system
Device name
Ion Endoluminal System
Model / reference
380748
Primary DI / UDI-DI
00886874116234
Basic UDI-DI
08868741211087J
FDA product code
EOQ
EMDN code
Z12020899 Pulmonary endoscopic instruments - other
GMDN term
Surgical planning/navigation-enhancement system
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: Surgical planning/navigation-enhancement system

Similar devices in this category

Other devices filed under PULMONARY ENDOSCOPIC INSTRUMENTS.

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)