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148 device results listed.

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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

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 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-123U

Vitamin B12 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-123U
Basic UDI-DI: B-TD-HNKX-CED-123U
Reference: /
EMDN: W0102070204
EMDN description: VITAMIN B12
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

Vitamin B₁₂ Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK020DC
Basic UDI-DI: B-SEK020DC
Reference: SE-K020
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-R20215ZH

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R20215ZH
Basic UDI-DI: B-R20215ZH
Reference: R20215
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-R20214ZF

30 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R20214ZF
Basic UDI-DI: B-R20214ZF
Reference: R20214
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-R20213ZD

200 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R20213ZD
Basic UDI-DI: B-R20213ZD
Reference: R20213
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-R20212ZB

100 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R20212ZB
Basic UDI-DI: B-R20212ZB
Reference: R20212
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-R20211Z9

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R20211Z9
Basic UDI-DI: B-R20211Z9
Reference: R20211
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:25

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Vitamin B12

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722905
Basic UDI-DI: 88001117IPBA01IA18WA
Reference: 16VITB10F
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403212HN

VB12 Chemiluminescent Binding Assay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403212HN
Basic UDI-DI: B-IM4403212HN
Reference: IM4403212
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4402212HF

VB12 Chemiluminescent Binding Assay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402212HF
Basic UDI-DI: B-IM4402212HF
Reference: IM4402212
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

VB12 Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD191XT
Basic UDI-DI: B-GKPD191XT
Reference: GKPD191
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin B12 Quantitative Test Kit (Time-Resolved FIA)

FIVB12-302a

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FIVB12-302aN2
Basic UDI-DI: B-FIVB12-302aN2
Reference: FIVB12-302a
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin B12 Quantitative Test Kit (Time-Resolved FIA)

FIVB12-302a

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FIVB12-302aHGRE
Basic UDI-DI: B-FIVB12-302aHGRE
Reference: FIVB12-302a
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Unicorn-Vitamin B12

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DT012577
Basic UDI-DI: B-DT012577
Reference: DT0125
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

Unicorn-Vitamin B12

5 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DT012475
Basic UDI-DI: B-DT012475
Reference: DT0124
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details