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430035

by Intuitive Surgical, Inc.

Ref 430035

430035 is a device classified as Class IIb in the EU and Class II in the US made by Intuitive Surgical, Inc., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 088687412295294) and listed in FDA GUDID since 20 Sep 2018 (UDI-DI 00886874114377), 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 Number088687412295294 Basic UDI-DI 00886874114377UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874114377 UDI-DI Date20 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 088687412295294 registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 00886874114377 listed 20 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874114377
  2. Registered EUDAMED 088687412295294

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  • Withdrawn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
Monopolar Curved Scissors Tip
Generic name
Manual scalpel blade, single-use
Device name
Monopolar Curved Scissors Tips
Model / reference
430035
Primary DI / UDI-DI
00886874114377
Basic UDI-DI
088687412295294
FDA product code
NAY
EMDN code
K020199 Mono- and bipolar devices, single use - other
GMDN term
Manual scalpel blade, single-use
Device class
Class IIb 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 IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Manual scalpel blade, single-use

Similar devices in this category

Other devices filed under MONO- AND BIPOLAR DEVICES, SINGLE USE - OTHER.

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)