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732 device results listed.

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Access AFP (300 & 600 Test Kit)

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590744403
Basic UDI-DI: 150995901AccAFP300PR
Reference: C28649
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 29.06.2026 13:40

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL β2-MG (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414799026
Basic UDI-DI: B-06954414799026
Reference: /
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details

Getein

MAGICL AFP-L3 (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798678
Basic UDI-DI: B-06954414798678
Reference: /
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
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

MAGICL S100 (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798630
Basic UDI-DI: B-06954414798630
Reference: /
EMDN: W0102039012
EMDN description: PROTEIN S-100 B
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:34

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL PIVKA-II (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798623
Basic UDI-DI: B-06954414798623
Reference: /
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:34

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL LN (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798500
Basic UDI-DI: B-06954414798500
Reference: /
EMDN: W0102039006
EMDN description: LAMININ
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:33

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL NSE (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798302
Basic UDI-DI: B-06954414798302
Reference: /
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:32

Manufacturer products Authorised representative products Authorised representative actors View details

Getein

MAGICL AFP (CLIA)

IVD generalIVDDOn the marketKitReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798234
Basic UDI-DI: B-06954414798234
Reference: /
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:32

Manufacturer products Authorised representative products Authorised representative actors View details

β2-MG 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: 06954414792683
Basic UDI-DI: 695441470211GT
Reference: IF5011
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414702392
Basic UDI-DI: B-06954414702392
Reference: /
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Transferrin and Fecal Occult Blood and Haptoglobinhemoglobin Combo Test Device

MT-F43M002

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817459
Basic UDI-DI: B-06952804817459
Reference: MT-F43M002
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

β2MG FIA

β2mg-W23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804803445
Basic UDI-DI: B-06952804803445
Reference: β2mg-W23F3
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
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

AFP FIA

AFP-W23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802844
Basic UDI-DI: B-06952804802844
Reference: AFP-W23F3
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

β2-microglobulin Chemiluminescence Immunoassay Test Kit

G217A08

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802462
Basic UDI-DI: B-06952804802462
Reference: G217A08
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha Fetoprotein Chemiluminescence Immunoassay Test Kit

G200A08

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802363
Basic UDI-DI: B-06952804802363
Reference: G200A08
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

06951045811530

100 tests

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

Manufacturer: Suzhou Sym-Bio Lifescience Co., Ltd.
Manufacturer SRN: CN-MF-000012847
UDI-DI: 06951045811530
Basic UDI-DI: 69510458SF_AFPVQ
Reference: SY490QG
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 28.06.2026 09:36

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha Fetoprotein (AFP) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334813798
Basic UDI-DI: B-06950334813798
Reference: 52026122
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays β2-Microglobulin (Latex Immunoturbidimetric)

β2-Microglobulin (Latex Immunoturbidimetric)

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

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145583514
Basic UDI-DI: 69471455612WC
Reference: 130553007A
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays β2-Microglobulin (Latex Immunoturbidimetric)

β2-Microglobulin (Latex Immunoturbidimetric)

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

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145583460
Basic UDI-DI: 69471455612WC
Reference: 130553007S
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI S-100 (CLIA)

S-100 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145501303
Basic UDI-DI: B-06947145501303
Reference: 130201017M
EMDN: W0102039012
EMDN description: PROTEIN S-100 B
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details