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IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627014580
Basic UDI-DI: 08476270BAGRETFS
Reference: RV1000M
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 23.07.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista System Diluent

IVDR_67_GLA_DUB-C_A_REAG_System Diluent

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016325
Basic UDI-DI: 0405686901043UU
Reference: 10445206
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista/Dimension EXL CTNI Sample Diluent

IVDR_67_GLA_DUB-C_A_REAG_CTNI SDIL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768015892
Basic UDI-DI: 0405686901029V2
Reference: 10445205
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension/Dimension Vista Enzyme Diluent

IVDR_67_GLA_DUB-C_A_REAG_Enzyme Diluent

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768000102
Basic UDI-DI: 0405686901031UM
Reference: 10444870
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Acid/Base

IVDR_67_TTN_DUB-C_A_REAG_Acid/Base

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595542
Basic UDI-DI: 0405686901541VH
Reference: 11098500
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:11

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Acid/Base Reagents

IVDR_67_TTN_DUB-C_A_REAG_Acid / Base Reagents

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414503875
Basic UDI-DI: 0405686901540VF
Reference: 10313526
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:10

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Insulin Diluent

IVDR_67_TTN_DUB-C_A_REAG_IRI_Dil

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414466187
Basic UDI-DI: 0405686900739VZ
Reference: 10310462
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:10

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Acid/Base Reagents

IVDR_67_TTN_DUB-C_A_REAG_Acid / Base

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414190860
Basic UDI-DI: 0405686901539VW
Reference: 10310026
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:10

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 FSH Sample Diluent

IVDR_67_LLB_DUB-C_A_REAG_FSH Sample Diluent

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414953786
Basic UDI-DI: 0405686901329VH
Reference: 10387064
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Estradiol Sample Diluent

IVDR_67_LLB_DUB-C_A_REAG_Estradiol Sample Diluent

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414953731
Basic UDI-DI: 0405686901327VD
Reference: 10387063
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

Buffer

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066779434
Basic UDI-DI: 697806677SE004NU
Reference: 6620-PA00008
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 21.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Buffer

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066779427
Basic UDI-DI: 697806677SE004NU
Reference: 6620-PA00007
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 21.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Buffer

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066779410
Basic UDI-DI: 697806677SE004NU
Reference: 6620-PA00006
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 21.07.2026 22:50

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: 00630414600475
Basic UDI-DI: 0405686900735VR
Reference: 10995631
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 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM cPSA Pretreatment Reagent (cPSA PRE)

IVDR_67_TTN_DUB-C_C_REAG_cPSA Pretreatment

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598703
Basic UDI-DI: 0405686901839WD
Reference: 10995546
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 CA 19-9 Diluent

IVDR_67_TTN_DUB-C_A_REAG_CA 19-9_Dil

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414577128
Basic UDI-DI: 0405686900736VT
Reference: 10491972
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 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