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+ENTIDNOV10002

Ferritin

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDNOV10002
Basic UDI-DI: B-+ENTIDNOV10002
Reference: DNOV100
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

STANDARD™ i Vitamin B12

i-VB12-01

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722899
Basic UDI-DI: 88001117IPBA01IA18WA
Reference: 16VITB10D
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Ferritin (Latex Immunoturbidimetric)

Ferritin (Latex Immunoturbidimetric)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145570910
Basic UDI-DI: 69471455605WF
Reference: 130510001A
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

ABX Pentra Ferritin 2 CP

A11A01900

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005606
Basic UDI-DI: 361023pentra_ferritin2WT
Reference: A11A01900
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: France
Authorised representative: -
Last updated: 16.07.2026 07:51

Manufacturer products View details

Atellica IM Vitamin D Total II (VitDII)

IVDR_67_TTN_DUB-C_B_REAG_KIT_VitDII

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414649863
Basic UDI-DI: 0405686902369W4
Reference: 11698628
EMDN: W0102070206
EMDN description: VITAMIN D (CHOLECALCIFEROL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Iron3 (Iron3)

IVDR_67_TTN_DUB-C_B_REAG_Iron3

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414610849
Basic UDI-DI: 0405686902345VN
Reference: 11537211
EMDN: W0102070106
EMDN description: IRON (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® VB12

IVDR_67_TTN_DUB-C_B_KIT_VB12

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177168
Basic UDI-DI: 0405686901638VZ
Reference: 10309970
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 EPO

IVDR_67_LLB_DUB-C_B_KIT_EPO

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414986210
Basic UDI-DI: 0405686901379VY
Reference: 10487629
EMDN: W0102070101
EMDN description: ERYTHROPOIETIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

N Latex Ferritin

IVDR_27_MAR EB_B_KIT _N_La_Ferr

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768008085
Basic UDI-DI: 0405686900881W5
Reference: 10446130
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:19

Manufacturer products View details

N Latex sTfR

IVDR_27_MAR EB_B_REAG_N_La_sTFR

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768008054
Basic UDI-DI: 0405686900964WA
Reference: 10446127
EMDN: W0102070104
EMDN description: SOLUBLE TRANSFERRIN RECEPTOR
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:19

Manufacturer products View details

ADVIA Centaur Vitamin D Total

IVDR_67_TTN_DUB-C_B_KIT_VitD

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414592503
Basic UDI-DI: 0405686900750VM
Reference: 10699201
EMDN: W0102070206
EMDN description: VITAMIN D (CHOLECALCIFEROL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:13

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL LOCI Vitamin B12 Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_VB12

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414976624
Basic UDI-DI: 0405686900207UT
Reference: 10463371
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:04

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Vitamin B12

IVDR_67_LLB_DUB-C_B_REAG_KIT_Vitamin B12

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414962313
Basic UDI-DI: 0405686900229V5
Reference: 10380914
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:03

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag Plus Hemoglobin Test Strips

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VOS01-01199
Basic UDI-DI: B-VOS01-01199
Reference: VOS01-011
EMDN: W0102070105
EMDN description: RETICULOCYTE HAEMOGLOBIN CONTENT
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:24

Manufacturer products Authorised representative products Authorised representative actors View details

Ferritin Test Kit (FIA)

VID28

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID2835
Basic UDI-DI: B-VID2835
Reference: VID28-07-011
EMDN: W0102070102
EMDN description: FERRITIN
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

VivaDiag Folate Test Kit (FIA)

VID129

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID129F5
Basic UDI-DI: B-VID129F5
Reference: VID129-07-011
EMDN: W0102070103
EMDN description: FOLATE
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 Vitamin B12 Test Kit (FIA)

VID128

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID128F3
Basic UDI-DI: B-VID128F3
Reference: VID128-07-011
EMDN: W0102070204
EMDN description: VITAMIN B12
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

Vitamin B12 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-VB12706-AECK
Basic UDI-DI: B-VB12706-AECK
Reference: VB12706-AE10Y, VB12706-AE10N, VB12706-AE20Y, VB12706-AE20N
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-1542

Ferritin 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-1542
Basic UDI-DI: B-TD-HNKX-CED-1542
Reference: /
EMDN: W0102070102
EMDN description: FERRITIN
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

D-TD-HNKX-CED-143Y

Folate Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-143Y
Basic UDI-DI: B-TD-HNKX-CED-143Y
Reference: /
EMDN: W0102070103
EMDN description: FOLATE
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