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Holder

by IceCure Medical Ltd.

Ref FAG3000000

Holder (FAG3000000) is a Class I device made by Icecure Medical Ltd., registered in EUDAMED on 12 Feb 2024 (Basic UDI-DI B-07290015487153) and listed in FDA GUDID since 19 Jan 2023 (UDI-DI 07290015487153), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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/MDD EUDAMED NumberB-07290015487153 Basic UDI-DI 07290015487153UDI-DIDate12 Feb 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number07290015487153 UDI-DI Date19 Jan 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07290015487153 registered 12 Feb 2024 Active
  • FDA GUDID UDI-DI 07290015487153 listed 19 Jan 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07290015487153
  2. Registered EUDAMED B-07290015487153

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Medical table clamp
Model / Ref / Catalog
FAG3000000
Primary DI / UDI-DI
07290015487153
Basic UDI-DI
B-07290015487153
FDA product code
MDM
EMDN code
L0318 Instruments for support of surgical devices, reusable
GMDN term
Medical table clamp
Device class
Class I
Regulation number
878.4800
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Manufacturer details

EUDAMED SRN
IL-MF-000026406
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Similar devices in this category

Other devices filed under INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE.

Other devices from Icecure Medical Ltd.

See all devices from Icecure Medical Ltd. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)