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Everest™ AC3200

by Medtronic, Inc.

Ref AC3200

Everest™ AC3200 is a device classified as Class I in the EU and Class II in the US made by Medtronic, Inc., registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-00763000338190) and listed in FDA GUDID since 27 May 2022 (UDI-DI 00763000338190), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00763000338190 Basic UDI-DI 00763000338190UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000338190 UDI-DI Date27 May 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00763000338190 registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 00763000338190 listed 27 May 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00763000338190
  2. Registered EUDAMED B-00763000338190

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  • Withdrawn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

Trade name
Everest™
Generic name
Catheter/overtube balloon inflator, single-use
Device name
Everest Inflation device
Model / reference
AC3200
Primary DI / UDI-DI
00763000338190
Basic UDI-DI
B-00763000338190
FDA product code
MAV
EMDN code
C0699 Cardiovascular surgery instruments, single-use - other
GMDN term
Catheter/overtube balloon inflator, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1650
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
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: Catheter/overtube balloon inflator, single-use

Similar devices in this category

Other devices filed under CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)