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Atellica IM AB12 10733001

by Siemens Healthcare Diagnostics Inc.

Ref 10733001Model IVDR_67_TTN_DUB-C_B_KIT_AB12

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 Number0405686901598WE Basic UDI-DI 00630414245720UDI-DIDate8 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414245720 UDI-DI Date19 Oct 2018ListedStatusListed 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  • Withdrawn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

Trade Name
Atellica IM Active-B12 (Holotranscobalamin) (AB12) EUDAMED
Atellica IM AB12 GUDID
Generic Name
Holotranscobalamin (holoTC) IVD, kit, chemiluminescent immunoassay
Device Name
IVDR_67_TTN_DUB-C_B_KIT_AB12
Model / Ref / Catalog
10733001, IVDR_67_TTN_DUB-C_B_KIT_AB12
Primary DI / UDI-DI
00630414245720
Basic UDI-DI
0405686901598WE
510(k) Number
FDA Product Code
CDD
EMDN Code
W0102070204 Vitamin b12
GMDN Term
Holotranscobalamin (holoTC) IVD, kit, chemiluminescent immunoassay
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
862.1810
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

Related devices

Category: Holotranscobalamin (holoTC) IVD, kit, chemiluminescent immunoassay

Cleared under the same submission (K160757)

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Animal Tissues
  • Microbial Substances
  • Professional Testing
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Reagent: 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