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PATHFAST B·R·A·H·M·S PCT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301155
Basic UDI-DI: 4987595PF1221KXD
Reference: 30115
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7022 · Rev. 5
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:40

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

Atellica IM Follicle Stimulating Hormone (FSH)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599052
Basic UDI-DI: 0405686901612VF
Reference: 10995581
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Testosterone II

IVDR_67_TTN_DUB-C_B_KIT_TSTII

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414591131
Basic UDI-DI: 0405686901634VR
Reference: 10696862
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur BRAHMS Procalcitonin

IVDR_67_TTN_DUB-C_C_KIT_PCT

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414246536
Basic UDI-DI: 0405686901818W5
Reference: 11202697
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Sex Hormone Binding Globulin (SHBG)

IVDR_67_TTN_DUB-C_B_KIT_SHBG

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599854
Basic UDI-DI: 0405686901626VS
Reference: 10995672
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Progesterone

IVDR_67_TTN_DUB-C_B_KIT_Progesterone

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414204147
Basic UDI-DI: 0405686901624VN
Reference: 10310305
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Prolactin

IVDR_67_TTN_DUB-C_B_KIT_PRL

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177267
Basic UDI-DI: 0405686901623VL
Reference: 10309975
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® FSH

IVDR_67_TTN_DUB-C_B_KIT_FSH

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177243
Basic UDI-DI: 0405686901612VF
Reference: 10309973
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® LH

IVDR_67_TTN_DUB-C_B_KIT_LH

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177229
Basic UDI-DI: 0405686901617VR
Reference: 10309971
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Gastrin-17 Test Kit (FIA)

VID59

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID593G
Basic UDI-DI: B-VID593G
Reference: VID59-06-011
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Mullerian Hormone Test Kit (FIA)

VID30

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID302Q
Basic UDI-DI: B-VID302Q
Reference: VID30-05-011
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

S100 Protein Test Kit (FIA)

VID139

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID139F8
Basic UDI-DI: B-VID139F8
Reference: VID139-07-011
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag Infection Combo (SAA/CRP) Test Kit (FIA)

VID110

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID110EG
Basic UDI-DI: B-VID110EG
Reference: VID110-01-011
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag Infection Combo (PCT/IL-6/CRP) Test Kit (FIA)

VID109

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID109EX
Basic UDI-DI: B-VID109EX
Reference: VID109-01-011
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Test Kit (FIA)

VID02

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID022K
Basic UDI-DI: B-VID022K
Reference: VID02-01-011
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-544C

Gastrin-17 Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-544C
Basic UDI-DI: B-TD-HNKX-CED-544C
Reference: /
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-454B

Pepsinogen I & Pepsinogen II Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-454B
Basic UDI-DI: B-TD-HNKX-CED-454B
Reference: /
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-1848

Procalcitonin Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-1848
Basic UDI-DI: B-TD-HNKX-CED-1848
Reference: /
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Luteinizing Hormone (LH)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599533
Basic UDI-DI: 0405686901617VR
Reference: 10995635
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 14.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Prolactin

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177274
Basic UDI-DI: 0405686901623VL
Reference: 10309976
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 14.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details