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100 Mixing Fleas + Magnet

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414115825
Basic UDI-DI: 0405686901918WA
Reference: 10311055
EMDN: W0501010203
EMDN description: BLOOD COLLECTION, CAPILLARY TUBES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.09.2026 03:11

Manufacturer products Authorised representative products Authorised representative actors View details

TB3 K+/Ca++/Cl- Test/Blank Sensor

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414132075
Basic UDI-DI: 0405686902184VN
Reference: 10311665
EMDN: W0201040185
EMDN description: BLOOD GAS ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.09.2026 03:11

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Collection Capillaries Multicap 100 x 60µl Kit

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414108766
Basic UDI-DI: 0405686901918WA
Reference: 10314213
EMDN: W0501010203
EMDN description: BLOOD COLLECTION, CAPILLARY TUBES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.09.2026 03:11

Manufacturer products Authorised representative products Authorised representative actors View details

Multistix 5

IVD Class BIVDR 2017/746On the marketMicrobial substancesNear-patient testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414984988
Basic UDI-DI: 0405686901963WF
Reference: 10318564
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.09.2026 02:51

Manufacturer products Authorised representative products Authorised representative actors View details

Albustix

IVD Class CIVDR 2017/746On the marketMicrobial substancesNear-patient testingReagentSelf testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414984971
Basic UDI-DI: 0405686901973WJ
Reference: 10317384
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: -
Safety summary (SSCP/SSP): DX026363 · Rev. 1.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.09.2026 02:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Multistix 10 SG

IVD Class BIVDR 2017/746On the marketMicrobial substancesNear-patient testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414975429
Basic UDI-DI: 0405686901963WF
Reference: 10313959
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.09.2026 02:51

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Atellica IM Hepatitis B e Antigen Quality Control (HBeAg QC)

IVD Class DIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599243
Basic UDI-DI: 0405686901896WR
Reference: 10995601
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: -
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_HBeAg_HBeAg QC · Rev. 4.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.09.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Atellica IM Hepatitis B e Antigen (HBeAg)

IVD Class DIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599236
Basic UDI-DI: 0405686901880WA
Reference: 10995600
EMDN: W0105020211
EMDN description: HEPATITIS B ANTIGEN
First on market country: -
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_HBeAg_HBeAg QC · Rev. 4.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.09.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Atellica IM Hepatitis B core IgM (aHBcM)

IVD Class DIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597799
Basic UDI-DI: 0405686901872WB
Reference: 10995449
EMDN: W0105020210
EMDN description: HEPATITIS B CORE ANTIBODY IGM
First on market country: -
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_aHBcM_aHBcM QC · Rev. 4.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.09.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Atellica IM Hepatitis C (aHCV)

IVD Class DIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597867
Basic UDI-DI: 0405686901874WF
Reference: 10995456
EMDN: W0105020301
EMDN description: HCV ANTIGEN
First on market country: -
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_HCV_HCV QC · Rev. 4.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.09.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ADVIA Centaur HBsAgII

IVD Class DIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414602905
Basic UDI-DI: 0405686901882WE
Reference: 10994742
EMDN: W0105020211
EMDN description: HEPATITIS B ANTIGEN
First on market country: -
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_HBsAgII_HBsAg Conf_QC · Rev. 10.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.09.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Atellica IM Hepatitis B surface Antigen II Confirmatory (HBsII Conf)

IVD Class DIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599267
Basic UDI-DI: 0405686901881WC
Reference: 10995603
EMDN: W0105020202
EMDN description: HEPATITIS B SURFACE ANTIGEN - CONFIRMATORY
First on market country: -
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_HBsAgII_HBsAg Conf_QC · Rev. 10.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.09.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Atellica HEMA Diluent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414289960
Basic UDI-DI: 0405686902208VB
Reference: 11374304
EMDN: W0102010114
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 23:51

Manufacturer products Authorised representative products Authorised representative actors View details

Rapidchem Reference Electrode

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414451893
Basic UDI-DI: 0405686901947WH
Reference: 10309034
EMDN: W0101070301
EMDN description: REFERENCE ELECTRODES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 23:51

Manufacturer products Authorised representative products Authorised representative actors View details

Ready Sensor - HCT

IVD Class CIVDR 2017/746On the marketAnimal tissuesNear-patient testingProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414056296
Basic UDI-DI: 0405686901946WF
Reference: 10309783
EMDN: W0101060606
EMDN description: BLOOD GAS BUFFERS AND SOLUTIONS - ELECTRODES OR CASSETTE
First on market country: -
Safety summary (SSCP/SSP): DX026402 · Rev. 1.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 23:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Atellica IM CMV IgM (CMV IgM)

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414612157
Basic UDI-DI: 0405686902044V5
Reference: 11202488
EMDN: W0105040204
EMDN description: CMV IGM
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 23:27

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM CMV IgM Quality Control (CMV IgM QC)

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414612034
Basic UDI-DI: 0405686902045V7
Reference: 11202489
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 23:27

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica HEMA 580 (SMS Ready)

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414289694
Basic UDI-DI: 0405686900784W6
Reference: 11315457
EMDN: W0202010102
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr)
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 23:27

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Squamous Cell Carcinoma (SCC)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414292380
Basic UDI-DI: 0405686902365VU
Reference: 11354594
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 23:27

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Enzymatic Creatinine Flex reagent cartridge

DX_LS_LEGACY_00842768036262

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768036262
Basic UDI-DI: B-00842768036262
Reference: 10700444
EMDN: W01010207
EMDN description: CREATININE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 23:23

Manufacturer products Authorised representative products Authorised representative actors View details