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ADVIA Centaur eE2 Diluent

IVDR_67_TTN_DUB-C_A_KIT_eE2 Diluent

IVD Class AIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414575100
Basic UDI-DI: 0405686901536VQ
Reference: 10491878
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur FOL Diluent

IVDR_67_TTN_DUB-C_A_REAG_Folate Diluent

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414451787
Basic UDI-DI: 0405686901558W2
Reference: 10310389
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur FOL Ascorbic Acid (lyophilized)/Ascorbic Acid Diluent

IVDR_67_TTN_DUB-C_B_REAG_Fol Ascorbic Acid/Ascorbic Acid Dil

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414451077
Basic UDI-DI: 0405686901557VY
Reference: 10316877
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur IgE Diluent

IVDR_67_TTN_DUB-C_A_REAG_IgE Diluent

IVD Class AIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414175331
Basic UDI-DI: 0405686901561VP
Reference: 10309952
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur cPSA Pretreatment Reagent

IVDR_67_TTN_DUB-C_C_REAG_cPSA Pretreatment

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414451558
Basic UDI-DI: 0405686901839WD
Reference: 10310384
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur T3/T4/VB12 Ancillary Reagent

IVDR_67_TTN_DUB-C_B_REAG_T3/T4/VB12 Ancillary Reagent

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414175386
Basic UDI-DI: 0405686901772W6
Reference: 10309954
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

16977376430049

300 Tests, 600 Tests

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Xiamen Talent Biomedical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000039397
UDI-DI: 16977376430049
Basic UDI-DI: 697737643DD23MY
Reference: 600 Tests
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 05:32

Manufacturer products Authorised representative products Authorised representative actors View details

GSD RPR Diluent

GSD01-1600-DIL

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Gold Standard Diagnostics, LLC
Manufacturer SRN: US-MF-000027142
UDI-DI: B350GSD011600DIL0
Basic UDI-DI: ++B350GSD011600DILQZ
Reference: GSD01-1600-DIL
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 05:20

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Insulin Diluent (IRI DIL)

IVDR_67_TTN_DUB-C_A_KIT_IRI_Dil

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600468
Basic UDI-DI: 0405686900735VR
Reference: 10995630
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 05:15

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Total IgE Diluent (tIgE DIL)

IVDR_67_TTN_DUB-C_A_REAG_IgE Diluent

IVD Class AIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599397
Basic UDI-DI: 0405686901561VP
Reference: 10995616
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 05:15

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM HCY DIL (diluent)

IVDR_67_TTN_DUB-C_A_REAG_HCY Diluent

IVD Class AIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599311
Basic UDI-DI: 0405686901560VM
Reference: 10995608
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 05:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Fol DTT/REL (releasing agent)

IVDR_67_TTN_DUB-C_B_REAG_Folate DTT / Releasing Agent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599007
Basic UDI-DI: 0405686901709VX
Reference: 10995576
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 05:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Fol DIL (diluent)

IVDR_67_TTN_DUB-C_A_REAG_Folate Diluent

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598987
Basic UDI-DI: 0405686901558W2
Reference: 10995574
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 05:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Enhanced Estradiol Diluent (eE2 DIL)

IVDR_67_TTN_DUB-C_A_KIT_eE2 Diluent

IVD Class AIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598871
Basic UDI-DI: 0405686901536VQ
Reference: 10995563
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 05:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM RBC Fol (ascorbic acid/diluent)

IVDR_67_TTN_DUB-C_B_REAG_Fol Ascorbic Acid/Ascorbic Acid Dil

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597690
Basic UDI-DI: 0405686901557VY
Reference: 10995440
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 05:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-600401MT

Schnelltest Gesunder Darm

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-600401MT
Basic UDI-DI: B-600401MT
Reference: 600401
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 17.07.2026 03:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-600400MR

Gesunder Darm

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-600400MR
Basic UDI-DI: B-600400MR
Reference: 600400
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 17.07.2026 03:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-569793559221729W

Urine Reagent Strips(Dry Chemical Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000050949
UDI-DI: D-569793559221729W
Basic UDI-DI: B-569793559221729W
Reference: 1 piece/bag x 100
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 17.07.2026 02:48

Manufacturer products Authorised representative products Authorised representative actors View details

50604724627496

Shigella Agglutination Sera

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Pro-Lab Diagnostics UK
Manufacturer SRN: GB-MF-000003833
UDI-DI: 50604724627496
Basic UDI-DI: B-50604724627496
Reference: PL.6903
EMDN: W01029001
EMDN description: ANTISERA (MONOVALENT AND POLYVALENT)
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 17.07.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

50604724627328

Shigella Agglutination Sera

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Pro-Lab Diagnostics UK
Manufacturer SRN: GB-MF-000003833
UDI-DI: 50604724627328
Basic UDI-DI: B-50604724627328
Reference: PL.6902
EMDN: W01029001
EMDN description: ANTISERA (MONOVALENT AND POLYVALENT)
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 17.07.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details