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Sundt™ NL8505063

by Integra Lifesciences Corp.

Ref NL8505063

Sundt NL8505063 is a carotid artery shunt (EU MDD Class III; FDA Class II; FDA product code DWF, Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass) made by Integra Lifesciences Corp., registered in EUDAMED on 11 Sep 2026 (Basic UDI-DI B-10381780211129) and listed in FDA GUDID since 20 Jun 2016 (UDI-DI 10381780211129), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780211129 Basic UDI-DI 10381780211129UDI-DIDate11 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780211129 UDI-DI Date20 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10381780211129 registered 11 Sep 2026 Active
  • FDA GUDID UDI-DI 10381780211129 listed 20 Jun 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10381780211129
  2. Registered EUDAMED B-10381780211129

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  • Withdrawn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
Sundt™
Generic name
Carotid artery shunt
Device name
Carotid Endarterectomy Shunts
Model / Ref / Catalog
NL8505063
Primary DI / UDI-DI
10381780211129
Basic UDI-DI
B-10381780211129
FDA product code
DWF
EMDN code
C019006 Carotid artery shunts
GMDN term
Carotid artery shunt
Device class
Class III EUDAMED
Class II GUDID
Regulation number
870.4210
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Carotid artery shunt

Similar devices in this category

Other devices filed under DEVICES FOR VASCULAR PROCEDURES - VARIOUS.

Other devices from Integra Lifesciences Corp.

See all devices from Integra Lifesciences Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)