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Hemoglobin 50X, R: 4 x 5 mL, CAL: 1 x 1 mL

IVD generalIVDDOn the marketAnimal tissuesKitReagentSingle use

Manufacturer: Chronolab Systems, S.L.
Manufacturer SRN: ES-MF-000017043
UDI-DI: D-084360386136135EH
Basic UDI-DI: B-084360386136135EH
Reference: 101-0368
EMDN: W0103010201
EMDN description: HAEMOGLOBIN DETERMINATIONS (TOTAL HB)
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:30

Manufacturer products View details

HEMOGLOBIN A2

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: FAR Srl
Manufacturer SRN: IT-MF-000041136
UDI-DI: 08034063842934
Basic UDI-DI: B-08034063842934
Reference: KR06-20
EMDN: W0103010202
EMDN description: HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 18:02

Manufacturer products View details

HbA2 & HbF & HbA1c Assay Kit (HPLC)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06977125152416
Basic UDI-DI: B-06977125152416
Reference: GHD200
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:11

Manufacturer products Authorised representative products Authorised representative actors View details

HbA2 & HbF & HbA1c Assay Kit (HPLC)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06977125152409
Basic UDI-DI: B-06977125152409
Reference: GHD100
EMDN: W0103010299
EMDN description: OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:11

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood (FOB) Test Kit (LIA)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hunan Hehao Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000029298
UDI-DI: 06975867980038
Basic UDI-DI: B-06975867980038
Reference: BQX2
EMDN: W0103010201
EMDN description: HAEMOGLOBIN DETERMINATIONS (TOTAL HB)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:16

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood (FOB) Test Kit (LIA)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hunan Hehao Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000029298
UDI-DI: 06975867980021
Basic UDI-DI: B-06975867980021
Reference: BQX1
EMDN: W0103010201
EMDN description: HAEMOGLOBIN DETERMINATIONS (TOTAL HB)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:16

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