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26014

by Atrium Medical Corporation

Ref 26014

26014 is a Class I device made by Atrium Medical Corporation, registered in EUDAMED on 7 Jun 2026 (Basic UDI-DI B-00650862260144) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 00650862260144), 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-00650862260144 Basic UDI-DI 00650862260144UDI-DIDate7 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00650862260144 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00650862260144 registered 7 Jun 2026 Active
  • FDA GUDID UDI-DI 00650862260144 listed 24 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00650862260144
  2. Registered EUDAMED B-00650862260144

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  • Withdrawn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
Vascular Graft Tunneler instrumentation
Generic name
Vascular graft tunneller
Device name
PV-1, Vascular Graft Tunneler Rod
Model / reference
26014
Primary DI / UDI-DI
00650862260144
Basic UDI-DI
B-00650862260144
FDA product code
DWS
EMDN code
L070805 Vascular tunnellers, reusable
GMDN term
Vascular graft tunneller
Device class
Class I
Regulation number
870.4500
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under CARDIOVASCULAR SURGERY INSTRUMENTS, REUSABLE.

Other devices from Atrium Medical Corporation

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (18, all answered No)