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292 device results listed.

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COVID-19/ InfluenzaA+B/RSV Antigen Combo Rapid Test

COVID-19/ Influenza A+B/RSV Antigen 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-RV-G45bZV
Basic UDI-DI: B-RV-G45bZV
Reference: RV-G45b
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 05:09

Manufacturer products Authorised representative products Authorised representative actors View details

6-MAM One Step 6-Monoacetylmorphine Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-6-MAM-A01a3R
Basic UDI-DI: B-6-MAM-A01a3R
Reference: 6-MAM-A01a
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 03:15

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5'-Nucleotidase Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-5-NT601DR
Basic UDI-DI: B-5-NT601DR
Reference: 5-NT6011Y, 5-NT6012Y, 5-NT6013Y, 5-NT6014Y, 5-NT6015Y, 5-NT6011N, 5-NT6012N, 5-NT6013N, 5-NT6014N, 5-NT6015N
EMDN: W01010101
EMDN description: 5'-NUCLEOTIDASE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 02:15

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tPAI·C Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-tPAIC706-AE5H
Basic UDI-DI: B-tPAIC706-AE5H
Reference: tPAI·C706-AE10Y, tPAI·C706-AE10N, tPAI·C706-AE20Y, tPAI·C706-AE20N
EMDN: W0103020507
EMDN description: TISSUE PLASMINOGEN ACTIVATOR
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

cTn-T Cardiac Troponin T (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-hs-cTnT706-AE3N
Basic UDI-DI: B-hs-cTnT706-AE3N
Reference: hs-cTnT706-AE10Y, hs-cTnT706-AE10N, hs-cTnT706-AE20Y, hs-cTnT706-AE20N
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:19

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cTn-I Cardiac Troponin I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-hs-cTnI706-AEVQ
Basic UDI-DI: B-hs-cTnI706-AEVQ
Reference: hs-cTnI706-AE10Y, hs-cTnI706-AE10N, hs-cTnI706-AE20Y, hs-cTnI706-AE20N
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:19

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hs-CRP High-sensitivity C-reactive Protein (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-hs-CRP706-AEUC
Basic UDI-DI: B-hs-CRP706-AEUC
Reference: hs-CRP706-AE10Y, hs-CRP706-AE10N, hs-CRP706-AE20Y, hs-CRP706-AE20N
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:19

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Cardiac Troponin I Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-cTnI601RE
Basic UDI-DI: B-cTnI601RE
Reference: cTnI6011Y, cTnI6012Y, cTnI6013Y, cTnI6014Y, cTnI6015Y, cTnI6011N, cTnI6012N, cTnI6013N, cTnI6014N, cTnI6015N
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-tTG IgG Anti-tissue Transglutaminase IgG Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-anti-tTG706-AEYS
Basic UDI-DI: B-anti-tTG706-AEYS
Reference: "anti-tTG706-AE10Y, anti-tTG706-AE10N, anti-tTG706-AE20Y, anti-tTG706-AE20N
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

α₂-Macroglobulin Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-a2-MG601AB
Basic UDI-DI: B-a2-MG601AB
Reference: α2-MG6011Y, α2-MG6012Y, α2-MG6013Y, α2-MG6014Y, α2-MG6015Y, α2-MG6011N, α2-MG6012N, α2-MG6013N, α2-MG6014N, α2-MG6015N
EMDN: W0102019003
EMDN description: A2-MACROGLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-dsDNA IgG Anti-double-stranded DNA IgG Antibody(CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-anti-dsDNA706-AEST
Basic UDI-DI: B-anti-dsDNA706-AEST
Reference: anti-dsDNA706-AE10Y, anti-dsDNA706-AE10N, anti-dsDNA706-AE20Y, anti-dsDNA706-AE20N
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

α₁-Microglobulin Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-a1-MG6019S
Basic UDI-DI: B-a1-MG6019S
Reference: α1-MG6011Y, α1-MG6012Y, α1-MG6013Y, α1-MG6014Y, α1-MG6015Y, α1-MG6011N, α1-MG6012N, α1-MG6013N, α1-MG6014N, α1-MG6015N
EMDN: W0102019004
EMDN description: A1-MICROGLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:18

Manufacturer products Authorised representative products Authorised representative actors View details

Zinc Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-Zn6018U
Basic UDI-DI: B-Zn6018U
Reference: Zn6011Y, Zn6012Y, Zn6013Y, Zn6014Y, Zn6015Y, Zn6011N, Zn6012N, Zn6013N, Zn6014N, Zn6015N
EMDN: W01010233
EMDN description: ZINC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:18

Manufacturer products Authorised representative products Authorised representative actors View details

Zika 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-ZIKA-D22aHA
Basic UDI-DI: B-ZIKA-D22aHA
Reference: ZIKA-D22a
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details

INS Insulin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-W0102060103CB
Basic UDI-DI: B-W0102060103CB
Reference: INS706-AE10Y, INS706-AE10N, INS706-AE20Y, INS706-AE20N
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

VPA Valproate(CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-VPA706-AE6V
Basic UDI-DI: B-VPA706-AE6V
Reference: VPA706-AE10Y, VPA706-AE10N, VPA706-AE20Y, VPA706-AE20N
EMDN: W0102080210
EMDN description: VALPROIC ACID
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 13:24

Manufacturer products Authorised representative products Authorised representative actors View details

VD Test Kit FIA

IVD generalIVDDOn the marketAnimal tissuesKitReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-VD-D06aTF
Basic UDI-DI: B-VD-D06aTF
Reference: VD-D06a
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 15.07.2026 13:15

Manufacturer products Authorised representative products Authorised representative actors View details

25-hydroxy Vitamin D Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-VD-D02aT3
Basic UDI-DI: B-VD-D02aT3
Reference: VD-D02a
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 13:15

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin B12 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-VB12706-AECK
Basic UDI-DI: B-VB12706-AECK
Reference: VB12706-AE10Y, VB12706-AE10N, VB12706-AE20Y, VB12706-AE20N
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

Urea Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-UREA6015P
Basic UDI-DI: B-UREA6015P
Reference: UREA6011Y, UREA6012Y, UREA6013Y, UREA6014Y, UREA6015Y, UREA6011N, UREA6012N, UREA6013N, UREA6014N, UREA6015N
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details