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17 device results listed.

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Human β - amyloid protein (Aβ1-42) Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD198Y9
Basic UDI-DI: B-GKPD198Y9
Reference: GKPD198
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:40

Manufacturer products Authorised representative products Authorised representative actors View details

Human β - amyloid protein (Aβ1-42) Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD145XL
Basic UDI-DI: B-GKPD145XL
Reference: GKPD145
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-CQ5771023F

HISCL β-Amyloid 1-42 Assay kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-CQ5771023F
Basic UDI-DI: B-CQ5771023F
Reference: CQ577102
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 07:20

Manufacturer products Authorised representative products Authorised representative actors View details

06975531323376

Cassette: 20 piece

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323376
Basic UDI-DI: B-06975531323376
Reference: /
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

06975531323369

Cassette: 5 piece

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323369
Basic UDI-DI: B-06975531323369
Reference: /
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

06975531323345

Cassette: 1 piece

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323345
Basic UDI-DI: B-06975531323345
Reference: /
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

Amyloid Beta (1-42) Rapid Test Kit (Fluorescence Immunochromatographic Assay)

Please see the IFU.

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hoyotek Biomedical Co.,Ltd.
Manufacturer SRN: CN-MF-000003570
UDI-DI: 06974738205263
Basic UDI-DI: B-06974738205263
Reference: IF21-01-40
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Amyloid Beta (1-42) Rapid Test Kit (Fluorescence Immunochromatographic Assay)

Please see the IFU.

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hoyotek Biomedical Co.,Ltd.
Manufacturer SRN: CN-MF-000003570
UDI-DI: 06974738205256
Basic UDI-DI: B-06974738205256
Reference: IF21-01-20
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Aβ1-42 Assay kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001041
Basic UDI-DI: B-06974521001041
Reference: SUPM091072
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

Aβ1-42 Assay kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001034
Basic UDI-DI: B-06974521001034
Reference: SUPM091036
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (SAA) Rapid Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000013536
UDI-DI: 06974464591517
Basic UDI-DI: B-06974464591517
Reference: 5064C4X025
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

06972719605385

Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719605385
Basic UDI-DI: B-06972719605385
Reference: 100tests/kit
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:49

Manufacturer products Authorised representative products Authorised representative actors View details

06972719605378

Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719605378
Basic UDI-DI: B-06972719605378
Reference: 50tests/kit
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:49

Manufacturer products Authorised representative products Authorised representative actors View details

06972719603312

Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719603312
Basic UDI-DI: B-06972719603312
Reference: 50tests/kit
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:42

Manufacturer products Authorised representative products Authorised representative actors View details

06972719603305

Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719603305
Basic UDI-DI: B-06972719603305
Reference: 50tests/kit
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:42

Manufacturer products Authorised representative products Authorised representative actors View details

06972719603299

Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719603299
Basic UDI-DI: B-06972719603299
Reference: 100tests/kit
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:42

Manufacturer products Authorised representative products Authorised representative actors View details

06972719601424

Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 100tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719601424
Basic UDI-DI: B-06972719601424
Reference: 100tests/kit
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:36

Manufacturer products Authorised representative products Authorised representative actors View details