Skip to content

EliA GliadinDP IgA Well

by Phadia AB 2 variants

Ref 14-6638-01

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

CE IVDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07333066025155 UDI-DI Date17 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number7333066BUDI0101LM Basic UDI-DI 07333066025155UDI-DIDate25 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic Name
Gliadin antibody IVD, kit, fluorescent immunoassay
Device Name
EliA GliadinDP IgA
Model / Ref / Catalog
14-6638-01 EUDAMED
DECC066380 GUDID
Primary DI / UDI-DI
07333066025155
Basic UDI-DI
7333066BUDI0101LM
FDA Product Code
MST
EMDN Code
W0102100604 Gliadin antibodies
GMDN Term
Gliadin antibody IVD, kit, fluorescent immunoassay
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
866.5750
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
14-6638-01
GUDID
DECC066380
Device ClassEUDAMED
Class B
GUDID
Class II

Manufacturer details

EUDAMED SRN
SE-MF-000014170

Other devices from Phadia AB

See all devices from Phadia AB →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No