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Dac-Nt

by St. Jude Medical, Inc.

Ref DAC-NT

Dac-Nt is a device classified as Class I in the EU and Class II in the US made by St. Jude Medical, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 5415067RFA0001EL) and listed in FDA GUDID since 10 Apr 2017 (UDI-DI 05415067028884), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5415067RFA0001EL Basic UDI-DI 05415067028884UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067028884 UDI-DI Date10 Apr 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5415067RFA0001EL registered 22 Oct 2026 Active
  • FDA GUDID UDI-DI 05415067028884 listed 10 Apr 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05415067028884
  2. Registered EUDAMED 5415067RFA0001EL

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  • Withdrawn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

Generic name
Electrical-only medical device connection cable, reusable
Device name
NeuroTherm Accessories
Model / Ref / Catalog
DAC-NT
Primary DI / UDI-DI
05415067028884
Basic UDI-DI
5415067RFA0001EL
FDA product code
IKD, GXD, GXI
EMDN code
Z1204021602 Portable pain therapy instruments
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
890.1175, 882.4400, 882.4725
EU registration type
Standard device
EU market of registration
Belgium
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.

Similar devices in this category

Other devices filed under PORTABLE MICROINFUSION INSTRUMENTS.

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)