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Atellica IM Anti-Thyroglobulin II (aTgII)

by Siemens Healthcare Diagnostics Products Ltd. 2 variants

Ref 11201761Model IVDR_67_LLB_DUB-C_B_KIT_aTgII

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686901371VG Basic UDI-DI 00630414245324UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414245324 UDI-DI Date4 Feb 2026ListedStatusListed 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 23 Oct 2026.

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  • Withdrawn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
Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
Device Name
IVDR_67_LLB_DUB-C_B_KIT_aTgII
Model / Ref / Catalog
IVDR_67_LLB_DUB-C_B_KIT_aTgII, 11201761
Primary DI / UDI-DI
00630414245324
Basic UDI-DI
0405686901371VG
510(k) Number
FDA Product Code
JZO
EMDN Code
W0102100303 Thyroglobulin autoantibody
GMDN Term
Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
866.5870
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class II

Manufacturer details

EUDAMED SRN
GB-MF-000016339
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763

Other devices from Siemens Healthcare Diagnostics Products Limited

See all devices from Siemens Healthcare Diagnostics Products Limited →

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