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Atellica HEMA TRANS. RIGHT MODULE SPS ONLY

by Siemens Healthcare Diagnostics Inc.

Ref 11315619Model IVDR_27_TTN_DUB-C_A_INST_RIGHT MODULE SPS ONLY

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686902210UW Basic UDI-DI 00630414289717UDI-DIDate3 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
IVDR_27_TTN_DUB-C_a_inst_right Module Sps Only
Model / Reference
IVDR_27_TTN_DUB-C_A_INST_RIGHT MODULE SPS ONLY, 11315619
Primary DI / UDI-DI
00630414289717
Basic UDI-DI
0405686902210UW
EMDN Code
W02029080 Various hematology / histology / cytology instruments - hardware accessories
Device Class
Class A
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000016560
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763

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Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No