Skip to content

490112

by Intuitive Surgical, Inc.

Ref 490112

490112 is a device classified as Class I in the EU and Class II in the US made by Intuitive Surgical, Inc., registered in EUDAMED on 4 Jun 2026 (Basic UDI-DI 08868741227478Z) and listed in FDA GUDID since 21 Mar 2019 (UDI-DI 00886874116852), 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 Number08868741227478Z Basic UDI-DI 00886874116852UDI-DIDate4 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874116852 UDI-DI Date21 Mar 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08868741227478Z registered 4 Jun 2026 Active
  • FDA GUDID UDI-DI 00886874116852 listed 21 Mar 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874116852
  2. Registered EUDAMED 08868741227478Z

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  • Withdrawn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 Continuity Stand
Generic name
Leakage current tester
Device name
Ion Reprocessing
Model / reference
490112
Primary DI / UDI-DI
00886874116852
Basic UDI-DI
08868741227478Z
FDA product code
EOQ
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Leakage current tester
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

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00886874116852: EUDAMED states Yes, FDA GUDID states No.

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: Leakage current tester

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

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