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Vitamin B12 CLIA Microparticles

AutoLumo Analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359551748
Basic UDI-DI: 697015090000074HD
Reference: CMS0303
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Vitamin B12 II

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912707974
Basic UDI-DI: 692591270036H6
Reference: C86064
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

ID-Vit® Vitamin B12

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598801202
Basic UDI-DI: B-04050598801202
Reference: KIF012
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

VIDAS® Vitamin B12 TOTAL

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026626419
Basic UDI-DI: 357302BUDI002227TN
Reference: 424106
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:00

Manufacturer products View details

Vitamin B12 （VB12）Diagnostic Kit ( Immunochromatographic Assay)

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762308
Basic UDI-DI: B-06971348762308
Reference: MF-93-25
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin B12 （VB12）Diagnostic Kit ( Immunochromatographic Assay)

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348761813
Basic UDI-DI: B-06971348761813
Reference: MF-93-20
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Vitamin B12 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852067
Basic UDI-DI: B-06933289852067
Reference: WA19P0004
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Vitamin B12 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852074
Basic UDI-DI: B-06933289852074
Reference: WA19P0005
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Vitamin B12 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852050
Basic UDI-DI: B-06933289852050
Reference: WA19P0003
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Vitamin B12 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852043
Basic UDI-DI: B-06933289852043
Reference: WA19P0002
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

06935784461409

BF S14

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784461409
Basic UDI-DI: B-06935784461409
Reference: BF-S141
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 19.07.2026 07:58

Manufacturer products Authorised representative products Authorised representative actors 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: 08800111722912
Basic UDI-DI: 88001117IPBA01IA18WA
Reference: 16VITB10Q
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 18.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S145RS

BF S14

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S145RS
Basic UDI-DI: B-CNMF000014455-BF-S145RS
Reference: BF-S145
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S144RQ

BF S14

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S144RQ
Basic UDI-DI: B-CNMF000014455-BF-S144RQ
Reference: BF-S144
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S143RN

BF S14

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S143RN
Basic UDI-DI: B-CNMF000014455-BF-S143RN
Reference: BF-S143
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S142RL

BF S14

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S142RL
Basic UDI-DI: B-CNMF000014455-BF-S142RL
Reference: BF-S142
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-93AT

Vitamin B12 (VB12) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-93AT
Basic UDI-DI: B-6-93AT
Reference: "REF: USIA00000231M, USIA00000232M"
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors 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

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