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813 device results listed.

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Neuron-Specific Enolase assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C09DU
Basic UDI-DI: B-7C09DU
Reference: 7C09V1-B-EU, 7C09U1-B-EU, 7C09P1-B-EU
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-Fetoprotein assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C01DC
Basic UDI-DI: B-7C01DC
Reference: 7C01V1-B-EU, 7C01U1-B-EU, 7C01P1-B-EU
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-76H50TXL
Basic UDI-DI: B-76H50TXL
Reference: 76H50T
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-76H50TSCVL
Basic UDI-DI: B-76H50TSCVL
Reference: 76H50TSC
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-76H150TAX
Basic UDI-DI: B-76H150TAX
Reference: 76H150T
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-76H150TSCBK
Basic UDI-DI: B-76H150TSCBK
Reference: 76H150TSC
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

D-3697P

Neuron-specific Enolase Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-3697P
Basic UDI-DI: B-3697P
Reference: /
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-3016M

Alpha1-fetoprotein Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-3016M
Basic UDI-DI: B-3016M
Reference: /
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-fetoprotein Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346311
Basic UDI-DI: B-20850076346311
Reference: CEAFP-301a
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:03

Manufacturer products Authorised representative products Authorised representative actors View details

D-1897K

Sialic Acid Assay Kit (Enzymatic Method)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-1897K
Basic UDI-DI: B-1897K
Reference: /
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 14:16

Manufacturer products Authorised representative products Authorised representative actors View details

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