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293 device results listed.

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cTnI/CK-MB/MYO Test Kit FIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CMC-D06a8R
Basic UDI-DI: B-CMC-D06a8R
Reference: CMC-D06a
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 05:08

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Creatine Kinase MB (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CKMB706-AERT
Basic UDI-DI: B-CKMB706-AERT
Reference: CKMB706-AE10Y, CKMB706-AE10N, CKMB706-AE20Y, CKMB706-AE20N
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CK601SA
Basic UDI-DI: B-CK601SA
Reference: CK6011Y, CK6012Y, CK6013Y, CK6014Y, CK6015Y, CK6011N, CK6012N, CK6013N, CK6014N, CK6015N
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB Isoenzyme Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CK-MB60175
Basic UDI-DI: B-CK-MB60175
Reference: CK-MB6011Y, CK-MB6012Y, CK-MB6013Y, CK-MB6014Y, CK-MB6015Y, CK-MB6011N, CK-MB6012N, CK-MB6013N, CK-MB6014N, CK-MB6015N
EMDN: W01010114
EMDN description: CREATINE KINASE - MB ACTIVITY (CC)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Test Kit FIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CK-MB-D06aL4
Basic UDI-DI: B-CK-MB-D06aL4
Reference: CK-MB-D06a
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

Chikungunya IgG/lgM Antibody Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CHIK-D02a2U
Basic UDI-DI: B-CHIK-D02a2U
Reference: CHIK-D02a
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 04:05

Manufacturer products Authorised representative products Authorised representative actors View details

Cholinesterase Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CHE6017D
Basic UDI-DI: B-CHE6017D
Reference: CHE6011Y, CHE6012Y, CHE6013Y, CHE6014Y, CHE6015Y, CHE6011N, CHE6012N, CHE6013N, CHE6014N, CHE6015N
EMDN: W01010111
EMDN description: CHOLINESTERASE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 04:05

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Carcinoembryonic Antigen (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CEA706-AEJL
Basic UDI-DI: B-CEA706-AEJL
Reference: CEA706-AE10Y, CEA706-AE10N, CEA706-AE20Y, CEA706-AE20N
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Test Kit FIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CEA-D06a3P
Basic UDI-DI: B-CEA-D06a3P
Reference: CEA-D06a
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 04:01

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CBZ Carbamazepine(CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CBZ706-AEW4
Basic UDI-DI: B-CBZ706-AEW4
Reference: CBZ706-AE10Y, CBZ706-AE10N, CBZ706-AE20Y, CBZ706-AE20N
EMDN: W0102080201
EMDN description: CARBAMAZEPINE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 03:55

Manufacturer products Authorised representative products Authorised representative actors View details

Calprotectin/FOB Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CAL/FOB-F22aQN
Basic UDI-DI: B-CAL/FOB-F22aQN
Reference: CAL/FOB-F22a
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 03:55

Manufacturer products Authorised representative products Authorised representative actors View details

Calprotectin Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CAL-F02a64
Basic UDI-DI: B-CAL-F02a64
Reference: CAL-F02a
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 03:55

Manufacturer products Authorised representative products Authorised representative actors View details

CA72-4 Cancer Antigen 72-4 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CA72-4706-AE5B
Basic UDI-DI: B-CA72-4706-AE5B
Reference: CA72-4706-AE10Y, CA72-4706-AE10N, CA72-4706-AE20Y, CA72-4706-AE20N
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 03:55

Manufacturer products Authorised representative products Authorised representative actors View details

CA50 Cancer Antigen 50 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CA50706-AETU
Basic UDI-DI: B-CA50706-AETU
Reference: CA50706-AE10Y, CA50706-AE10N, CA50706-AE20Y, CA50706-AE20N
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 03:55

Manufacturer products Authorised representative products Authorised representative actors View details

CA242 Cancer Antigen 242 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CA242706-AEEK
Basic UDI-DI: B-CA242706-AEEK
Reference: CA242706-AE10Y, CA242706-AE10N, CA242706-AE20Y, CA242706-AE20N
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 03:55

Manufacturer products Authorised representative products Authorised representative actors View details

CA15-3 Cancer Antigen 15-3 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CA15-3706-AEZE
Basic UDI-DI: B-CA15-3706-AEZE
Reference: CA15-3706-AE10Y, CA15-3706-AE10N, CA15-3706-AE20Y, CA15-3706-AE20N
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 03:55

Manufacturer products Authorised representative products Authorised representative actors View details

CA125 Cancer Antigen 125 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CA125706-AEE9
Basic UDI-DI: B-CA125706-AEE9
Reference: CA125706-AE10Y, CA125706-AE10N, CA125706-AE20Y, CA125706-AE20N
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 03:55

Manufacturer products Authorised representative products Authorised representative actors View details

Complement 4 Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-C4601MG
Basic UDI-DI: B-C4601MG
Reference: C46011Y, C46011Y, C46011Y, C46011Y, C46011Y, C46011N, C46011N, C46011N, C46011N, C46011N
EMDN: W0102010205
EMDN description: COMPLEMENT COMPONENT C4
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 03:54

Manufacturer products Authorised representative products Authorised representative actors View details

Complement 3 Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-C3601M9
Basic UDI-DI: B-C3601M9
Reference: C36011Y, C36011Y, C36011Y, C36011Y, C36011Y, C36011N, C36011N, C36011N, C36011N, C36011N
EMDN: W0102010203
EMDN description: COMPLEMENT COMPONENT C3/C3C
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

C-P C-Peptide (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-C-P706-AECW
Basic UDI-DI: B-C-P706-AECW
Reference: C-P706-AE10Y, C-P706-AE10N, C-P706-AE20Y, C-P706-AE20N
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 03:46

Manufacturer products Authorised representative products Authorised representative actors View details