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430013

by Intuitive Surgical, Inc.

Ref 430013

430013 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 28 Aug 2026 (Basic UDI-DI 08868741229218R) and listed in FDA GUDID since 20 Sep 2018 (UDI-DI 00886874113486), 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 Number08868741229218R Basic UDI-DI 00886874113486UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874113486 UDI-DI Date20 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08868741229218R registered 28 Aug 2026 Active
  • FDA GUDID UDI-DI 00886874113486 listed 20 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874113486
  2. Registered EUDAMED 08868741229218R

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  • Withdrawn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
Instrument Arm Drape
Generic name
Medical equipment/instrument drape, single-use
Device name
Sterile Drapes
Model / reference
430013
Primary DI / UDI-DI
00886874113486
Basic UDI-DI
08868741229218R
FDA product code
NAY, PUI
EMDN code
T020102 Specialistic surgery drapes
GMDN term
Medical equipment/instrument drape, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500, 878.4370
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 I
GUDID
Class II

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: Medical equipment/instrument drape, single-use

Similar devices in this category

Other devices filed under SPECIALISTIC SURGERY DRAPES.

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)