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293 device results listed.

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Immunoglobulin G Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-IgG601K7
Basic UDI-DI: B-IgG601K7
Reference: IgG6011Y, IgG6012Y, IgG6013Y, IgG6014Y, IgG6015Y, IgG6011N, IgG6012N, IgG6013N, IgG6014N, IgG6015N
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 02:16

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TIgE Total Immunoglobulin E (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-IgE706-AEAC
Basic UDI-DI: B-IgE706-AEAC
Reference: IgE706-AE10Y, IgE706-AE10N, IgE706-AE20Y, IgE706-AE20N
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 02:16

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Immunoglobulin A Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-IgA601HV
Basic UDI-DI: B-IgA601HV
Reference: IgA6011Y, IgA6012Y, IgA6013Y, IgA6014Y, IgA6015Y, IgA6011N, IgA6012N, IgA6013N, IgA6014N, IgA6015N
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 02:16

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IL-6 Interleukin-6 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-IL-6706-AE7Q
Basic UDI-DI: B-IL-6706-AE7Q
Reference: IL-6706-AE10Y, IL-6706-AE10N, IL-6706-AE20Y, IL-6706-AE20N
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 01:10

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IGF-1 Insulin-Like Growth Factor 1 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-IGF-1706-AE2V
Basic UDI-DI: B-IGF-1706-AE2V
Reference: IGF-1706-AE10Y, IGF-1706-AE10N, IGF-1706-AE20Y, IGF-1706-AE20N
EMDN: W0102060403
EMDN description: INSULIN-LIKE GROWTH FACTOR I (SOMATOMEDIN C)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 01:09

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Hp Ab Helicobacter Pylori Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-HpAb706-AEUN
Basic UDI-DI: B-HpAb706-AEUN
Reference: HpAb706-AE10Y, HpAb706-AE10N, HpAb706-AE20Y, HpAb706-AE20N
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 01:02

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Glycohemoglobin A1c Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-HbA1c601Q8
Basic UDI-DI: B-HbA1c601Q8
Reference: HbA1c6011Y, HbA1c6012Y, HbA1c6013Y, HbA1c6014Y, HbA1c6015Y, HbA1c6011N, HbA1c6012N, HbA1c6013N, HbA1c6014N, HbA1c6015N
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:59

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Glycohemoglobin A1c Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-HbA1c-S601EZ
Basic UDI-DI: B-HbA1c-S601EZ
Reference: HbA1c-S6011Y,HbA1c-S6012Y,HbA1c-S6013Y,HbA1c-S6014Y,HbA1c-S6015Y,HbA1c-S6011N,HbA1c-S6012N,HbA1c-S6013N,HbA1c-S6014N
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:59

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HSV - 1 IgG Herpes Simplex Virus Type 1 IgG Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-HSV2IgG706-AEED
Basic UDI-DI: B-HSV2IgG706-AEED
Reference: HSV1IgG706-AE10Y, HSV1IgG706-AE10N, HSV1IgG706-AE20Y, HSV1IgG706-AE20N
EMDN: W0105040306
EMDN description: HSV 1 IGG
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:57

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HSV - 2 IgG Herpes Simplex Virus Type 2 IgG Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-HSV1IgG706-AEDG
Basic UDI-DI: B-HSV1IgG706-AEDG
Reference: HSV2IgG706-AE10Y, HSV2IgG706-AE10N, HSV2IgG706-AE20Y, HSV2IgG706-AE20N
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:57

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HSV IgG/IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-HSV-D02aN9
Basic UDI-DI: B-HSV-D02aN9
Reference: HSV-D02a
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:57

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High Sensitivity 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-HS-CRP6018H
Basic UDI-DI: B-HS-CRP6018H
Reference: HS-CRP6011Y,HS-CRP6012Y,HS-CRP6013Y,HS-CRP6014Y,HS-CRP6015Y,HS-CRP6011N,HS-CRP6012N,HS-CRP6013N,HS-CRP6014N,HS-CRP6015N
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:57

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H. Pylori 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-HP-F02aQX
Basic UDI-DI: B-HP-F02aQX
Reference: HP-F02a
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

H. Pylori 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-HP-D02aQH
Basic UDI-DI: B-HP-D02aQH
Reference: HP-D02a, HP-D01a
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

HE4 Human Epididymal Protein 4 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-HE4706-AEFT
Basic UDI-DI: B-HE4706-AEFT
Reference: HE4706-AE10Y, HE4706-AE10N, HE4706-AE20Y, HE4706-AE20N
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

High Density Lipoprotein Cholesterol Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-HDL-C60185
Basic UDI-DI: B-HDL-C60185
Reference: HDL-C6011Y, HDL-C6012Y, HDL-C6013Y, HDL-C6014Y, HDL-C6015Y, HDL-C6011N, HDL-C6012N, HDL-C6013N, HDL-C6014N, HDL-C6015N
EMDN: W01010215
EMDN description: HIGH DENSITY LIPOPROTEIN CHOLESTEROL
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

Homocysteine Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-HCY601C3
Basic UDI-DI: B-HCY601C3
Reference: HCY6011Y, HCY6012Y, HCY6013Y, HCY6014Y, HCY6015Y, HCY6011N, HCY6012N, HCY6013N, HCY6014N, HCY6015N
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

β-HCG 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-HCG-D06a82
Basic UDI-DI: B-HCG-D06a82
Reference: β-HCG-D06a
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1C 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-HBA1C-D06aFH
Basic UDI-DI: B-HBA1C-D06aFH
Reference: HBA1C-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: 14.07.2026 00:52

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Anti-HAV Hepatitis A Virus Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-HAVAb706-AEA7
Basic UDI-DI: B-HAVAb706-AEA7
Reference: HAVAb706-AE10Y, HAVAb706-AE10N, HAVAb706-AE20Y, HAVAb706-AE20N
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:52

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