Siemens Healthcare Diagnostics Inc.
United States US-MF-000016336 Last updated 23 Oct 2026
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- Devices
- 2,093
- Registries
- EUDAMEDGUDIDFDA
- FDA recalls
- 0
Catalogue
Atellica IM Hyaluronic Acid (HA) Ref 10995595
Atellica IM free PSA II (fPSAII) Ref 11202221
ADVIA Centaur CMV IgM (CMV IgM) Ref 10630614
Dimension Vista Cuvette Waste Container Liner Ref 10445214
Atellica CH Wide Range C-Reactive Protein (wrCRP) Ref 11097645
Atellica HEMA 570 (SMS Ready) Ref 11315453
RAPIDPoint 500e Blood Gas Analyzer Ref 11416755
RL348EX Starter Kit + Cl ROW Ref 10844683
Multistix 8 SG Ref 10322217
RAPIDPoint 500 Blood Gas Analyzer Ref 10697306
Multistix GP Ref 10321054
CLINITEK Microalbumin 2 Ref 10318739
Multistix 10 SG Ref 10319133
RAPIDLab 348EX System Ref 10844678
Atellica VTLi Docking Station Ref 11555591
Multistix 8 SG Ref 10329509
Atellica UAS 800 Cuvettes Ref 11065553
Proficiency Survey Quick Adapter Ref 10492250
CLINITEK Novus PRO 12 Urinalysis Cassette Ref 10634644
CLINITEK Microalbumin 9 Ref 10285741
CLINITEK Microalbumin 2 Ref 10317957
Multistix 8 SG Ref 10320335
Quick Disposable Ampule Adapter Ref 10329817
CLINITEK Status+ Analyzer Ref 10379681
Atellica HEMA Calibrator 11374312 Ref 11374312
Atellica HEMA Diluent 11374304 Ref 11374304
Atellica HEMA Cleaner 11374306 Ref 11374306
Atellica HEMA Control (N) 11374314 Ref 11374314
Atellica HEMA RET/PLTO 11374309 Ref 11374309
Atellica HEMA Control (L) 11374313 Ref 11374313
Atellica HEMA Baso 11374308 Ref 11374308
Atellica HEMA Control (H) 11374315 Ref 11374315
Atellica HEMA Retic Control (L) 11374316 Ref 11374316
Atellica HEMA Retic Control (H) 11374318 Ref 11374318
Atellica HEMA Control BF (N) 11374319 Ref 11374319
Atellica HEMA Control BF (H) 11374320 Ref 11374320
Atellica IM CYFRA 21-1 11354591 Ref 11354591
Siemens Healthineers CYFRA 21-1 MCM 11536187 Ref 11536187
Atellica IM CYFRA 21-1 MCM 11536188 Ref 11536188
Atellica IM aTPOII MCM 11203694 Ref 11203694
ADVIA Centaur aTPOII MCM 11203693 Ref 11203693
Atellica CH Crea3 11537215 Ref 11537215
Atellica HEMA SMS W-G Stain 11559862 Ref 11559862
Atellica HEMA SMS W-G Buffer 11559863 Ref 11559863
Atellica HEMA SMS M-W Buffer 11559865 Ref 11559865
Atellica IM CYFRA21-1 Calibrator 11553957 Ref 11553957
Showing 1-50 of 2,093
EUDAMED certificates
TÜV Rheinland LGA Products GmbH 0197 22 certificates
- IX 1290554-35 Issued
Technical documentation EU IVDR
- Issued
- 18 Jul 2025
- Expires
- 17 Jul 2030
- IX 1290554-36 Issued
Technical documentation EU IVDR
- Issued
- 14 Jul 2025
- Expires
- 13 Jul 2030
- IX 1290554-11 Issued
Technical documentation EU IVDR
- Issued
- 9 Dec 2024
- Expires
- 8 Dec 2029
- IX 1290554-14 Issued
Technical documentation EU IVDR
- Issued
- 9 Dec 2024
- Expires
- 8 Dec 2029
- IX 1290554-30 Issued
Technical documentation EU IVDR
- Issued
- 12 Mar 2024
- Expires
- 11 Mar 2029
- IX 1290554-31 Issued
Technical documentation EU IVDR
- Issued
- 7 Mar 2024
- Expires
- 6 Mar 2029
- IX 1290554-12 Issued
Technical documentation EU IVDR
- Issued
- 2 Feb 2024
- Expires
- 1 Feb 2029
- IX 1290554-23 Issued
Technical documentation EU IVDR
- Issued
- 1 Sep 2023
- Expires
- 31 Aug 2028
- IX 1290554-25 Supplemented
Technical documentation EU IVDR
- Issued
- 17 Jul 2024
- Expires
- 1 Aug 2028
- Reason
- Add device or group
- IX 1290554-28 Issued
Technical documentation EU IVDR
- Issued
- 3 Jul 2024
- Expires
- 1 Aug 2028
- IX 1290554-1 Issued
Technical documentation EU IVDR
- Issued
- 3 Jul 2023
- Expires
- 2 Jul 2028
- IX 1290554-16 Issued
Technical documentation EU IVDR
- Issued
- 3 Jul 2023
- Expires
- 2 Jul 2028
- IX 1290554-10 Issued
Technical documentation EU IVDR
- Issued
- 27 Nov 2025
- Expires
- 25 Jun 2028
- IX 1290554-7 Issued
Technical documentation EU IVDR
- Issued
- 12 May 2025
- Expires
- 5 Jun 2028
- IX 1290554-8 Amended
Technical documentation EU IVDR
- Issued
- 12 May 2025
- Expires
- 5 Jun 2028
- Reason
- Other
- IX 1290554-20 Issued
Technical documentation EU IVDR
- Issued
- 6 Sep 2024
- Expires
- 6 Mar 2028
- IX 1290554-17 Issued
Technical documentation EU IVDR
- Issued
- 2 Nov 2022
- Expires
- 26 Sep 2027
- IX 1290554-18 Issued
Technical documentation EU IVDR
- Issued
- 18 Aug 2022
- Expires
- 17 Aug 2027
- HX 7091841-1 Restricted
Quality management system EU IVDR
- Issued
- 26 Aug 2026
- Expires
- 7 Mar 2027
- Reason
- Not on market
- HX 1290554-1 Supplemented
Quality management system EU IVDR
- Issued
- 5 Oct 2026
- Expires
- 3 Mar 2027
- Reason
- Add device or group
- HX 7091841-1 Supplemented
Quality management system EU IVDR
- Issued
- 6 Feb 2026
- Expires
- 26 Oct 2026
- Reason
- Add device or group
- HX 1290554-1 Expired
Quality management system EU IVDR
- Issued
- 29 Mar 2026
- Expires
- 15 Sep 2026
- Reason
- Add device or group
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About
We pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Discover more about our innovative medtech and the people behind it.
Information
- Country
- United States
- Address
- 511, Benedict Avenue, Tarrytown, United States
- Website
- www.siemens-healthineers.com
- facebook.com/SiemensHealthineers
- [email protected]
- Phone
- +1 877 229 3711
- PRRC contact
- Robert Brennan
- EUDAMED SRN
- US-MF-000016336
- FDA FEI number
- 2432235
- DUNS number
- 005088112