Skip to content

ADVIA Centaur® cPSA 10310381

by Siemens Healthcare Diagnostics Inc.

Ref 10310381Model IVDR_67_TTN_DUB-C_C_KIT_cPSA

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 Number0405686901806VW Basic UDI-DI 00630414450896UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414450896 UDI-DI Date24 Sep 2014ListedStatusListed 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  • Withdrawn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
ADVIA Centaur® cPSA
Generic Name
Complexed prostate specific antigen (cPSA) IVD, kit, chemiluminescent immunoassay
Device Name
IVDR_67_TTN_DUB-C_C_KIT_cPSA
Model / Ref / Catalog
10310381, IVDR_67_TTN_DUB-C_C_KIT_cPSA, 124830
Primary DI / UDI-DI
00630414450896
Basic UDI-DI
0405686901806VW
PMA Number
FDA Product Code
NAF
EMDN Code
W0102030115 Complexed prostatic specific antigen
GMDN Term
Complexed prostate specific antigen (cPSA) IVD, kit, chemiluminescent immunoassay
Device Class
Class C EUDAMED
Class III GUDID
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class C
GUDID
Class III

Related devices

Cleared under the same submission (P990055)

Show all (9)

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

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

Other properties (18)

  • Sterile: 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
  • 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