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Atellica Im Elf Kit 11208118

by Siemens Healthcare Diagnostics Inc.

Ref 11208118Model DX LS_LEGACY_00630414618463

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

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00630414618463 Basic UDI-DI 00630414618463UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414618463 UDI-DI Date15 Mar 2023ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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 (ELF) EUDAMED
Atellica Im Elf Kit GUDID
Generic Name
Multiple liver fibrosis marker IVD, kit, chemiluminescent immunoassay
Device Name
Dx LS_LEGACY_00630414618463
Model / Ref / Catalog
11208118, DX LS_LEGACY_00630414618463
Primary DI / UDI-DI
00630414618463
Basic UDI-DI
B-00630414618463
De Novo Number
FDA Product Code
QQB
EMDN Code
W0102120199 Liver function - other
GMDN Term
Multiple liver fibrosis marker IVD, kit, chemiluminescent immunoassay
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
862.1622
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 II

Related devices

Category: Multiple liver fibrosis marker IVD, kit, chemiluminescent immunoassay

Cleared under the same submission (DEN190056)

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

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

Other properties (18)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No