Skip to content

430075

by Intuitive Surgical, Inc.

Ref 430075

430075 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 19 Aug 2026 (Basic UDI-DI 088687412294597) and listed in FDA GUDID since 11 Mar 2021 (UDI-DI 00886874119556), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number088687412294597 Basic UDI-DI 00886874119556UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874119556 UDI-DI Date11 Mar 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 088687412294597 registered 19 Aug 2026 Active
  • FDA GUDID UDI-DI 00886874119556 listed 11 Mar 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874119556
  2. Registered EUDAMED 088687412294597

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  • Withdrawn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 Access Port Kit, Large incision (2.7cm-7cm)
Generic name
Laparoscopic multi-instrument access port, single-use
Device name
Insertion kits
Model / reference
430075
Primary DI / UDI-DI
00886874119556
Basic UDI-DI
088687412294597
FDA product code
NAY
EMDN code
K01020299 Robotic surgery instrument, single-use - other
GMDN term
Laparoscopic multi-instrument access port, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
France
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: Laparoscopic multi-instrument access port, single-use

Similar devices in this category

Other devices filed under MINIMALLY INVASIVE AND ROBOTIC SURGERY INSTRUMENTS, SINGLE-USE.

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)