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Immunalysis 04Z46-10

by Immunalysis Corporation

Ref 04Z46-10

Immunalysis 04Z46-10 is a device classified as IVD General (EU), Class I (US) made by Immunalysis Corporation, registered in EUDAMED on 31 Aug 2026 (Basic UDI-DI B-00840937111581) and listed in FDA GUDID since 28 Feb 2019 (UDI-DI 00840937111581), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

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/IVDD EUDAMED NumberB-00840937111581 Basic UDI-DI 00840937111581UDI-DIDate31 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840937111581 UDI-DI Date28 Feb 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00840937111581 registered 31 Aug 2026 Active
  • FDA GUDID UDI-DI 00840937111581 listed 28 Feb 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840937111581
  2. Registered EUDAMED B-00840937111581

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Immunalysis
Generic name
Tramadol IVD, control
Model / Ref / Catalog
04Z46-10
Primary DI / UDI-DI
00840937111581
Basic UDI-DI
B-00840937111581
FDA product code
DIF
EMDN code
W0102152009 Controls for narcotics / toxicology
GMDN term
Tramadol IVD, control
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.3280
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 IVD General
GUDID
Class I

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

Related devices

Category: Tramadol IVD, control

Similar devices in this category

Other devices filed under CONTROLS FOR NARCOTICS / TOXICOLOGY.

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Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)