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Atellica IM Enhanced Liver Fibrosis Quality Control (ELF QC) 10995566

by Siemens Healthcare Diagnostics Inc.

Ref 10995566Model DX LS_LEGACY_00630414598901

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

CE IVDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00630414598901 Basic UDI-DI 00630414598901UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414598901 UDI-DI Date8 Aug 2025ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Atellica IM Enhanced Liver Fibrosis Quality Control (ELF QC)
Generic Name
Multiple liver fibrosis marker IVD, control
Device Name
Dx LS_LEGACY_00630414598901
Model / Ref / Catalog
10995566, DX LS_LEGACY_00630414598901
Primary DI / UDI-DI
00630414598901
Basic UDI-DI
B-00630414598901
FDA Product Code
JJX
EMDN Code
W0102152099 Controls- immunochemistry - other
GMDN Term
Multiple liver fibrosis marker IVD, control
Device Class
Class IVD General EUDAMED
Class I GUDID
Regulation Number
862.1660
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IVD General
GUDID
Class I

Related devices

Category: Multiple liver fibrosis marker IVD, control

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

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