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292 device results listed.

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Calcium Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-Ca-ARS601A4
Basic UDI-DI: B-Ca-ARS601A4
Reference: Ca-ARS6011Y,Ca-ARS6012Y,Ca-ARS6013Y,Ca-ARS6014Y,Ca-ARS6015Y,Ca-ARS6011N,Ca-ARS6012N,Ca-ARS6013N,Ca-ARS6014N,Ca-ARS6015N
EMDN: W01010303
EMDN description: CALCIUM
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 14:13

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Cystatin C Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CYS-C601K6
Basic UDI-DI: B-CYS-C601K6
Reference: CYS-C6011Y, CYS-C6012Y, CYS-C6013Y, CYS-C6014Y, CYS-C6015Y, CYS-C6011N, CYS-C6012N, CYS-C6013N, CYS-C6014N, CYS-C6015N
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 13:39

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CYFRA21-1 Cytokeratin 19 Fragments (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CY21-1706-AEMQ
Basic UDI-DI: B-CY21-1706-AEMQ
Reference: CY21-1706-AE10Y, CY21-1706-AE10N, CY21-1706-AE20Y, CY21-1706-AE20N
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 13:39

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cTnT 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-CTNT-D06aGN
Basic UDI-DI: B-CTNT-D06aGN
Reference: CTNT-D06a
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 13:35

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cTnI 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-CTNI-D06aC7
Basic UDI-DI: B-CTNI-D06aC7
Reference: CTNI-D06a
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 13:34

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cTnI Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CTNI-D02aBT
Basic UDI-DI: B-CTNI-D02aBT
Reference: CTNI-D02a
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 13:34

Manufacturer products Authorised representative products Authorised representative actors View details

CT Calcitonin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CT706-AE58
Basic UDI-DI: B-CT706-AE58
Reference: CT706-AE10Y, CT706-AE10N, CT706-AE20Y, CT706-AE20N
EMDN: W0102060301
EMDN description: CALCITONIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 13:34

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C-Reactive Protein Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CRP601D8
Basic UDI-DI: B-CRP601D8
Reference: CRP6011Y, CRP6012Y, CRP6013Y, CRP6014Y, CRP6015Y, CRP6011N, CRP6012N, CRP6013N, CRP6014N, CRP6015N
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 07:20

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CRP/SAA 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-CRP/SAA-D26aCN
Basic UDI-DI: B-CRP/SAA-D26aCN
Reference: CRP/SAA-D26a
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 07:20

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hsCRP 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-CRP-D06aGP
Basic UDI-DI: B-CRP-D06aGP
Reference: CRP-D06a
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 07:20

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CRP-D02aGB
Basic UDI-DI: B-CRP-D02aGB
Reference: CRP-D02a
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 07:20

Manufacturer products Authorised representative products Authorised representative actors View details

Creatinine Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CRE-E601A7
Basic UDI-DI: B-CRE-E601A7
Reference: CRE-E6011Y, CRE-E6012Y, CRE-E6013Y, CRE-E6014Y, CRE-E6015Y, CRE-E6011N, CRE-E6012N, CRE-E6013N, CRE-E6014N, CRE-E6015N
EMDN: W01010207
EMDN description: CREATININE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 07:20

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COVID-19 Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-COVID-19-B026L
Basic UDI-DI: B-COVID-19-B026L
Reference: COVID-19-B02
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 07:19

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19&Influenza A+B Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-COV/FLU-B35aM3
Basic UDI-DI: B-COV/FLU-B35aM3
Reference: COV/FLU-B35a
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 07:19

Manufacturer products Authorised representative products Authorised representative actors View details

Cortisol (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-COR706-AEZK
Basic UDI-DI: B-COR706-AEZK
Reference: COR706-AE10Y, COR706-AE10N, COR706-AE20Y, COR706-AE20N
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 07:19

Manufacturer products Authorised representative products Authorised representative actors View details

Cortisol Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-COR-J02aGU
Basic UDI-DI: B-COR-J02aGU
Reference: COR-J02a
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 07:19

Manufacturer products Authorised representative products Authorised representative actors View details

Cortisol 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-COR-D06aFW
Basic UDI-DI: B-COR-D06aFW
Reference: COR-D06a
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 07:19

Manufacturer products Authorised representative products Authorised representative actors View details

COD One Step Codeine Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-COD-A01a94
Basic UDI-DI: B-COD-A01a94
Reference: COD-A01a
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 07:09

Manufacturer products Authorised representative products Authorised representative actors View details

Carbon Dioxide Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CO26015U
Basic UDI-DI: B-CO26015U
Reference: CO26011Y, CO26012Y, CO26013Y, CO26014Y, CO26015Y, CO26011N, CO26012N, CO26013N, CO26014N, CO26015N
EMDN: W0101070108
EMDN description: CARBON DIOXIDE (BICARBONATE) - ELECTRODES (CC)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 07:09

Manufacturer products Authorised representative products Authorised representative actors View details

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