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Neonatal GALT

by Wallac Oy 2 variants

Ref NG-4100

Neonatal GALT (NG-4100) is a device classified as IVD General (EU), Class II (US) made by Wallac Oy, registered in EUDAMED on 30 May 2025 (Basic UDI-DI B-06438147001279), cleared under FDA 510(k) K950803 on 21 Sep 1995 and listed in FDA GUDID since 2 Feb 2016 (UDI-DI 06438147001279), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K950803

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-06438147001279 Basic UDI-DI 06438147001279UDI-DIDate30 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06438147001279 UDI-DI Date2 Feb 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK950803 Date21 Sep 1995DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06438147001279 registered 30 May 2025 Active
  • FDA 510(k) K950803 decided 21 Sep 1995 Active
  • FDA GUDID UDI-DI 06438147001279 listed 2 Feb 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-1139-03 FDA Unclassified (pre-2012) initiated 27 Jun 2003 on shared 510(k) K950803

    The kits are producing lower values than expected, which may result in an increase of false positive test results.

    • Terminated Z-0898-03 FDA Unclassified (pre-2012) initiated 8 Jan 2003 on shared 510(k) K950803

    The Control Cards are incorrectly labeled such that the normal 'N' and abnormal 'A' values are reversed.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

  1. Cleared FDA 510(k) K950803
  2. Recall initiated FDA recalls Z-0898-03
  3. Recall initiated FDA recalls Z-1139-03
  4. Listed FDA GUDID 06438147001279
  5. Registered EUDAMED B-06438147001279

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Neonatal GALT EUDAMED
Neonatal GALT kit GUDID
Generic name
Galactose-1-phosphate uridyl transferase IVD, kit, enzyme fluorescence
Model / Ref / Catalog
NG-4100
Primary DI / UDI-DI
06438147001279
Basic UDI-DI
B-06438147001279
510(k) Number
FDA product code
KQP
EMDN code
W01010199 Enzymes - other
GMDN term
Galactose-1-phosphate uridyl transferase IVD, kit, enzyme fluorescence
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1315
EU registration type
Legacy device (under a directive)
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
FI-MF-000022620

Similar devices in this category

Other devices filed under ENZYMES - OTHER.

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Properties

  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)