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Endowrist SP 430077

by Intuitive Surgical, Inc.

Ref 430077

Endowrist SP 430077 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 088687412283997) and listed in FDA GUDID since 28 Jan 2022 (UDI-DI 00886874122228), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number088687412283997 Basic UDI-DI 00886874122228UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874122228 UDI-DI Date28 Jan 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 088687412283997 registered 19 Aug 2026 Active
  • FDA GUDID UDI-DI 00886874122228 listed 28 Jan 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874122228
  2. Registered EUDAMED 088687412283997

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  • Withdrawn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, 0° EUDAMED
Endowrist SP GUDID
Generic name
Rigid optical laparoscope
Device name
Endoscopes
Model / reference
430077
Primary DI / UDI-DI
00886874122228
Basic UDI-DI
088687412283997
Direct marketing DI
00886874122228
FDA product code
IZI, NAY
EMDN code
Z12029016 Video laparoscopes
GMDN term
Rigid optical laparoscope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1600, 876.1500
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 6 Millimeter

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: Rigid optical laparoscope

Similar devices in this category

Other devices filed under VIDEO LAPAROSCOPES.

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)