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Atellica IM Squamous Cell Carcinoma (SCC)

IVDR_67_TTN_DUB-C_C_REAG_SCC

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414292366
Basic UDI-DI: 0405686902365VU
Reference: 11354595
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

High G/L

IVDR_69_TTN_DUB-C_C_NPT_REAG_BG-RapidPoint

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414121628
Basic UDI-DI: 0405686901969WT
Reference: 10311387
EMDN: W0101060607
EMDN description: BLOOD GAS CONTROLS -ELECTRODES OR CASSETTE
First on market country: Germany
Safety summary (SSCP/SSP): DX031033 · Rev. 1.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 09:00

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

Atellica HEMA Diluent

IVDR_27_TTN_DUB-C_A_REAG_Diluent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414289953
Basic UDI-DI: 0405686902208VB
Reference: 11374303
EMDN: W0102010114
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 09:00

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ADVIA Centaur Anti-HBe2 Quality Control (aHBe2 QC)

IVDR_67_TTN_DUB-C_D_REAG_KIT_aHBe2 QC

IVD Class DIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414167947
Basic UDI-DI: 0405686902260VD
Reference: 10720832
EMDN: W0105020211
EMDN description: HEPATITIS B ANTIGEN
First on market country: Germany
Safety summary (SSCP/SSP): ADVIA Centaur® Anti-HBe2 (aHBe2) · Rev. 03
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 09:00

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ADVIA Centaur Anti-HBe2 (aHBe2)

IVDR_67_TTN_DUB-C_D_REAG_KIT_aHBe2

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414167923
Basic UDI-DI: 0405686902259VU
Reference: 10720831
EMDN: W0105020211
EMDN description: HEPATITIS B ANTIGEN
First on market country: Germany
Safety summary (SSCP/SSP): ADVIA Centaur® Anti-HBe2 (aHBe2) · Rev. 03
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 09:00

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

TB2 pH/NA Test/Blank Sensor

IVDR_69_TTN_DUB-C_A_NPT_REAG_BG-RL1200/348EX

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414112275
Basic UDI-DI: 0405686902184VN
Reference: 10311030
EMDN: W0201040185
EMDN description: BLOOD GAS ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® Reagent Dispense Area Tag [RDA-Tag]

Tissue-Tek Genie® Accessories (Auxiliary Products)

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233002389
Basic UDI-DI: 06152338226JA
Reference: 8618-G090
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 24.09.2026 08:59

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Not Applicable

BD Molecular LBC Sample Buffer Tubes

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904439232
Basic UDI-DI: 038290PEBGAXBO4H
Reference: 443923
EMDN: W0104010204
EMDN description: SAMPLE TRANSPORT FOR NA TESTING
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 24.09.2026 08:56

Manufacturer products Authorised representative products Authorised representative actors View details

MutaPLATE® GST-P1 (TM)

MutaPLATE® GST-P1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598010888
Basic UDI-DI: B-04050598010888
Reference: KF1903132
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 08:56

Manufacturer products View details

Centrifuge 5804 R

Centrifuge 5804; Centrifuge 5804R; Centrifuge 5810; Centrifuge 5810R

IVD Class AIVDR 2017/746On the market

Manufacturer: Eppendorf SE
Manufacturer SRN: DE-MF-000006237
UDI-DI: 04043758052538
Basic UDI-DI: 04043758-IA-CEN-001-NQ
Reference: 5805950015
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 08:53

Manufacturer products View details

HuMax HCT

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Human Gesellschaft für Biochemica und Diagnostica mbH
Manufacturer SRN: DE-MF-000025590
UDI-DI: 04033145164562
Basic UDI-DI: 04033145LQ15500PT
Reference: 15500
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 08:53

Manufacturer products View details

BCAA Test

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598001053
Basic UDI-DI: B-04050598001053
Reference: K 7016
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 08:53

Manufacturer products View details

IMMULITE 2000 Nesting Cups 1mL for 12-mm and 13-mm sample tubes

IVDR_27_LLB_DUB-C_A_INST_Nesting Cups

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414982403
Basic UDI-DI: 0405686901002UE
Reference: 10374178
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:52

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur anti-HBs2

IVDR_67_TTN_DUB-C_D_KIT_Anti-HBs2

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414561790
Basic UDI-DI: 0405686901876WK
Reference: 10286268
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_aHBs2_aHBs2 QC · Rev. 5.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:52

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

ADVIA Centaur HBc Total 2 (HBcT2) Quality Control

IVDR_67_LLB_DUB-C_D_REAG_HBc Total 2 QC

IVD Class DIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414561233
Basic UDI-DI: 0405686901505VD
Reference: 10376699
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_HBcT2_HBcT2 QC · Rev. 4.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:52

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

ADVIA Centaur HBc Total 2 (HBcT2)

IVDR_67_LLB_DUB-C_D_KIT_HBc Total 2

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414561226
Basic UDI-DI: 0405686901498W9
Reference: 10376698
EMDN: W0105020208
EMDN description: HEPATITIS B CORE ANTIBODY (TOTAL)
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_HBcT2_HBcT2 QC · Rev. 4.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:52

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

ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control

IVDR_67_TTN_DUB-C_D_REAG_Anti-HBs2 QC

IVD Class DIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414551777
Basic UDI-DI: 0405686901890WD
Reference: 10283088
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_aHBs2_aHBs2 QC · Rev. 5.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:52

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

ADVIA Centaur CHIV

IVDR_67_TTN_DUB-C_D_KIT_HIV Ag/Ab Combo

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414551487
Basic UDI-DI: 0405686901884WJ
Reference: 10283020
EMDN: W0105030404
EMDN description: HIV MULTIPLE AG/AB COMBI TEST
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_CHIV_CHIV QC · Rev. 6.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:52

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

ADVIA Centaur HBeAg (HBe) Quality Control

IVDR_67_TTN_DUB-C_D_REAG_Hepatitis B e Antigen QC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414510668
Basic UDI-DI: 0405686901896WR
Reference: 10291296
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_HBeAg_HBeAg QC · Rev. 4.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:52

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

ADVIA Centaur Hepatitis B e Antigen

IVDR_67_TTN_DUB-C_D_KIT_HBeAg

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414510651
Basic UDI-DI: 0405686901880WA
Reference: 10291295
EMDN: W0105020211
EMDN description: HEPATITIS B ANTIGEN
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_HBeAg_HBeAg QC · Rev. 4.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:51

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