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243 device results listed.

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TestNOW® - Vitamin B12 Quantitative Test

1177Q-25

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Affimedix, Inc.
Manufacturer SRN: US-MF-000053178
UDI-DI: 00850082432196
Basic UDI-DI: B-00850082432196
Reference: 1177Q-25
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 05.07.2026 11:05

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin B12 Test Kit (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807186065R9
Basic UDI-DI: B-000012807186065R9
Reference: HWTS-OT109
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

CHORUS CLIA VIT B12

CVITB-C

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

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891328498
Basic UDI-DI: 803389132CVITB-C0096
Reference: 82252
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:19

Manufacturer products View details

EliA Intrinsic Factor Well

EliA Intrinsic Factor

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066015774
Basic UDI-DI: 7333066BUDI0124LZ
Reference: 14-5668-01
EMDN: W0102070205
EMDN description: INTRINSIC FACTOR (BLOCKING ANTIBODY)
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:17

Manufacturer products View details

Vitamin B12 Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465231656
Basic UDI-DI: 697846523VitaminB02LD
Reference: 2×100 test
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

25-hydroxy Vitamin D Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465231557
Basic UDI-DI: 697846523VitaminB01LB
Reference: 2×100 test
EMDN: W0102070206
EMDN description: VITAMIN D (CHOLECALCIFEROL)
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH-VD (CLIA)

1152

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Sophonix Co., Ltd.
Manufacturer SRN: CN-MF-000021894
UDI-DI: 06974183541152
Basic UDI-DI: 6974183541152B2
Reference: 1152
EMDN: W0102070299
EMDN description: VITAMIN TESTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

06973224892512

30 Tests/kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: 06973224892512
Basic UDI-DI: 6973224890038AK
Reference: DC76036
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:25

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ VITAMIN B12

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405448
Basic UDI-DI: 693971640902M8
Reference: 010902001
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:23

Manufacturer products Authorised representative products Authorised representative actors View details

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: 06970150909055
Basic UDI-DI: 697015090000074HD
Reference: CMS0302
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL Vitamin B12 (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798760
Basic UDI-DI: B-06954414798760
Reference: /
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:34

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin B12 Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414724325
Basic UDI-DI: 695441470258HM
Reference: IF5070
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin B12 Chemiluminescence Immunoassay Test Kit

G703A08

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804815561
Basic UDI-DI: B-06952804815561
Reference: G703A08
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin B12 FIA

VB12-W23F3

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804803209
Basic UDI-DI: B-06952804803209
Reference: VB12-W23F3
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:24

Manufacturer products Authorised representative products Authorised representative actors View details

06950617420958

IM4402212 EIM4406212 IM4403212 EIM4407212

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617420958
Basic UDI-DI: 69506174IM440212D5
Reference: EIM4407212
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

06950617420941

IM4402212 EIM4406212 IM4403212 EIM4407212

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617420941
Basic UDI-DI: 69506174IM440212D5
Reference: EIM4406212
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

06950617401773

IM4402212 EIM4406212 IM4403212 EIM4407212

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617401773
Basic UDI-DI: 69506174IM440212D5
Reference: IM4403212
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:35

Manufacturer products Authorised representative products Authorised representative actors View details

06950617401766

IM4402212 EIM4406212 IM4403212 EIM4407212

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617401766
Basic UDI-DI: 69506174IM440212D5
Reference: IM4402212
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:35

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin B12 CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293590292
Basic UDI-DI: 697518250F124042B
Reference: F12404
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin B12 Determination Kit (Fluorescence Immunochromatographic Assay)

25 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle useSterile

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293581153
Basic UDI-DI: 697518250P1130665
Reference: P11306
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 19:24

Manufacturer products Authorised representative products Authorised representative actors View details