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430020

by Intuitive Surgical, Inc.

Ref 430020

430020 is a device classified as Class IIa in the EU and Class II in the US made by Intuitive Surgical, Inc., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 08868741229148U) and listed in FDA GUDID since 20 Sep 2018 (UDI-DI 00886874114353), 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 Number08868741229148U Basic UDI-DI 00886874114353UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874114353 UDI-DI Date20 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08868741229148U registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 00886874114353 listed 20 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874114353
  2. Registered EUDAMED 08868741229148U

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  • Withdrawn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
SP Endoscope Sheath
Generic name
Optical medical device procedural cover
Device name
Instrument Sheaths
Model / reference
430020
Primary DI / UDI-DI
00886874114353
Basic UDI-DI
08868741229148U
FDA product code
NAY
EMDN code
Z12029085 Various instruments for endoscopy and mini-invasive surgery - consumables
GMDN term
Optical medical device procedural cover
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Sweden
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: Optical medical device procedural cover

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - CONSUMABLES.

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)