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430048

by Intuitive Surgical, Inc.

Ref 430048

430048 is a Class I device made by Intuitive Surgical, Inc., registered in EUDAMED on 4 Jun 2026 (Basic UDI-DI 08868741230417R) and listed in FDA GUDID since 20 Sep 2018 (UDI-DI 00886874115688), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08868741230417R Basic UDI-DI 00886874115688UDI-DIDate4 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874115688 UDI-DI Date20 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08868741230417R registered 4 Jun 2026 Active
  • FDA GUDID UDI-DI 00886874115688 listed 20 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874115688
  2. Registered EUDAMED 08868741230417R

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  • Withdrawn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 Cleaning and Sterilization Kit
Generic name
Surgical instrument/endoscope cleaning utensil, reusable
Device name
Cleaning and Sterilization Kit
Model / reference
430048
Primary DI / UDI-DI
00886874115688
Basic UDI-DI
08868741230417R
FDA product code
MNL, FFY
EMDN code
V0799 Products for cleaning medical devices not included in other classes - other
GMDN term
Surgical instrument/endoscope cleaning utensil, reusable
Device class
Class I
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)