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490107

by Intuitive Surgical, Inc.

Ref 490107

490107 is an endoscope sheath (EU MDR Class I; FDA Class II; FDA product code EOQ, Bronchoscope (flexible or rigid)) made by Intuitive Surgical, Inc., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 08868741227308G) and listed in FDA GUDID since 21 Mar 2019 (UDI-DI 00886874116289), 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 Number08868741227308G Basic UDI-DI 00886874116289UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874116289 UDI-DI Date21 Mar 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08868741227308G registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 00886874116289 listed 21 Mar 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874116289
  2. Registered EUDAMED 08868741227308G

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  • Withdrawn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
Catheter Guide
Generic name
Endoscope sheath, reusable
Model / reference
490107
Primary DI / UDI-DI
00886874116289
Basic UDI-DI
08868741227308G
Direct marketing DI
00886874116289
FDA product code
EOQ
EMDN code
R020202 Mobile catheter mounts
GMDN term
Endoscope sheath, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.4680
EU registration type
Standard device
EU market of registration
Germany
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: Endoscope sheath, reusable

Similar devices in this category

Other devices filed under MOBILE CATHETER MOUNTS.

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

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