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811 device results listed.

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Tissue-Tek Genie®

Tissue-Tek Genie® anti-Ki67 Mouse Monoclonal Antibody [GM027]

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

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233010674
Basic UDI-DI: 06152338275JP
Reference: 8276-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie®

Tissue-Tek Genie® anti-CD10 Rabbit Monoclonal Antibody [QR021]

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

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233010605
Basic UDI-DI: 06152338296JX
Reference: 8386-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie®

Tissue-Tek Genie® anti-HER2 Rabbit Monoclonal Antibody [EP3]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233010582
Basic UDI-DI: 06152338271JF
Reference: 8388-M250
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie®

Tissue-Tek Genie® anti-CD3 Mouse Monoclonal Antibody [ZM45]

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

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233010391
Basic UDI-DI: 06152338274JM
Reference: 8344-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie®

Tissue-Tek Genie® anti-CD3 Rabbit Monoclonal Antibody [EP177]

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

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233000996
Basic UDI-DI: 06152338223J4
Reference: 8280-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® AFP

IVDR_67_TTN_DUB-C_C_KIT_Alpha Fetoprotein

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177328
Basic UDI-DI: 0405686901798WQ
Reference: 10309979
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
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

N Latex ß2-Microglobulin

IVDR_27_MAR EB_C_KIT_N_La_ß2-Mic

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768008412
Basic UDI-DI: 0405686900963W8
Reference: 10446161
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:19

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Neuron-Specific Enolase Test Kit (FIA)

VID102

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID102EH
Basic UDI-DI: B-VID102EH
Reference: VID102-06-011
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

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Beta-2 Microglobulin Test Kit (FIA)

VID07

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID072V
Basic UDI-DI: B-VID072V
Reference: VID07-02-011
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-594N

Beta-2-microglobulin Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-594N
Basic UDI-DI: B-TD-HNKX-CED-594N
Reference: /
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-494K

Fecal Occult Blood Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-494K
Basic UDI-DI: B-TD-HNKX-CED-494K
Reference: /
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-484H

Alpha-fetoprotein Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-484H
Basic UDI-DI: B-TD-HNKX-CED-484H
Reference: /
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-4347

S100-beta protein Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-4347
Basic UDI-DI: B-TD-HNKX-CED-4347
Reference: /
EMDN: W0102039012
EMDN description: PROTEIN S-100 B
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK001D8
Basic UDI-DI: B-SEK001D8
Reference: SE-K001
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
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

BGI

50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022030E7
Basic UDI-DI: B-SAC2022030E7
Reference: SAC2022030
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022029EN
Basic UDI-DI: B-SAC2022029EN
Reference: SAC2022029
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

10 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022028EL
Basic UDI-DI: B-SAC2022028EL
Reference: SAC2022028
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

5 tests/kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022007EC
Basic UDI-DI: B-SAC2022007EC
Reference: SAC2022007
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:34

Manufacturer products View details

D-R197153Z

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R197153Z
Basic UDI-DI: B-R197153Z
Reference: R19715
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-R197143X

30 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R197143X
Basic UDI-DI: B-R197143X
Reference: R19714
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:24

Manufacturer products Authorised representative products Authorised representative actors View details