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112 device results listed.

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Alzheimer' s Disease Rapid Urine Test Kit

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: LYHN-MY-ZC-03094
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.09.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Alzheimer' s Disease Rapid Urine Test Kit

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: LYHN-MY-ZC-03093
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.09.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Alzheimer' s Disease Rapid Urine Test Kit

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: LYHN-MY-ZC-03091
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.09.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Alzheimer' s Disease Rapid Urine Test Kit

Cassette: 2 piece

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323352
Basic UDI-DI: B-06975531323352
Reference: LYHN-MY-ZC-03092
EMDN: W0102019013
EMDN description: BETA-AMYLOID (1-40)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.09.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

06975531323673

Eluent1: 800mL×1bag

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323673
Basic UDI-DI: B-06975531323673
Reference: /
EMDN: W0103010202
EMDN description: HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 23:38

Manufacturer products Authorised representative products Authorised representative actors View details

06975531323666

Eluent2: 800mL×1bag

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323666
Basic UDI-DI: B-06975531323666
Reference: /
EMDN: W0103010202
EMDN description: HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 23:38

Manufacturer products Authorised representative products Authorised representative actors View details

06975531323659

Eluent3: 800mL×1bag

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323659
Basic UDI-DI: B-06975531323659
Reference: /
EMDN: W0103010202
EMDN description: HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 23:38

Manufacturer products Authorised representative products Authorised representative actors View details

06975531323642

Hemolysis & Wash Solution:2L×1bottle

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323642
Basic UDI-DI: B-06975531323642
Reference: /
EMDN: W0103010202
EMDN description: HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 23:38

Manufacturer products Authorised representative products Authorised representative actors View details

06975531323635

150Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323635
Basic UDI-DI: B-06975531323635
Reference: /
EMDN: W0103010202
EMDN description: HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 23:38

Manufacturer products Authorised representative products Authorised representative actors View details

06975531323628

200Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323628
Basic UDI-DI: B-06975531323628
Reference: /
EMDN: W0103010202
EMDN description: HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 23:38

Manufacturer products Authorised representative products Authorised representative actors View details

06975531323604

Calibrator 1～2：2×0.1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323604
Basic UDI-DI: B-06975531323604
Reference: /
EMDN: W0103010202
EMDN description: HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 23:38

Manufacturer products Authorised representative products Authorised representative actors View details

06975531323598

Calibrator 1～2：2×0.2mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323598
Basic UDI-DI: B-06975531323598
Reference: /
EMDN: W0103010202
EMDN description: HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)
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

06975531323581

Control1～2：2×0.2mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323581
Basic UDI-DI: B-06975531323581
Reference: /
EMDN: W0103010202
EMDN description: HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)
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

06975531323574

Control1～2：4×0.2mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323574
Basic UDI-DI: B-06975531323574
Reference: /
EMDN: W0103010202
EMDN description: HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)
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

06975531323567

Eluent1: 800mL×1bag

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323567
Basic UDI-DI: B-06975531323567
Reference: /
EMDN: W0103010202
EMDN description: HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)
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

06975531323536

Hemolysis & Wash Solution:2L×1bottle

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323536
Basic UDI-DI: B-06975531323536
Reference: /
EMDN: W0103010202
EMDN description: HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)
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

06975531323529

150Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323529
Basic UDI-DI: B-06975531323529
Reference: /
EMDN: W0103010202
EMDN description: HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)
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

06975531323550

Eluent2: 800mL×1bag

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323550
Basic UDI-DI: B-06975531323550
Reference: /
EMDN: W0103010202
EMDN description: HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)
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

06975531323543

Eluent3: 800mL×1bag

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323543
Basic UDI-DI: B-06975531323543
Reference: /
EMDN: W0103010202
EMDN description: HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)
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

06975531323512

200Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AILEX(Hunan)Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000043377
UDI-DI: 06975531323512
Basic UDI-DI: B-06975531323512
Reference: /
EMDN: W0103010202
EMDN description: HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)
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