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292 device results listed.

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Cholesterol Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-TC601WD
Basic UDI-DI: B-TC601WD
Reference: TC6011Y, TC6012Y, TC6013Y, TC6014Y, TC6015Y, TC6011N, TC6012N, TC6013N, TC6014N, TC6015N
EMDN: W01010205
EMDN description: CHOLESTEROL
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 10:55

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Total Bilirubin Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-TB601W6
Basic UDI-DI: B-TB601W6
Reference: TB6011Y, TB6012Y, TB6013Y, TB6014Y, TB6015Y, TB6011N, TB6012N, TB6013N, TB6014N, TB6015N TB6021Y, TB6022Y
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 10:55

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Total Bilirubin Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-TB-V601T9
Basic UDI-DI: B-TB-V601T9
Reference: TB-V6011Y, TB-V6012Y, TB-V6013Y, TB-V6014Y, TB-V6015Y, TB-V6011N, TB-V6012N, TB-V6013N, TB-V6014N, TB-V6015N
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 10:54

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Total β-HCG Total β-Human Chorionic Gonadotropin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-TB-HCG706-AEN4
Basic UDI-DI: B-TB-HCG706-AEN4
Reference: TB-HCG706-AE10Y, TB-HCG706-AE10N, TB-HCG706-AE20Y, TB-HCG706-AE20N
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 10:54

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Tuberculosis (TB) 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-TB-D22aRH
Basic UDI-DI: B-TB-D22aRH
Reference: TB-D22a
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 10:54

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TAT Thrombin-Antithrombin III Complex (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-TAT706-AE6M
Basic UDI-DI: B-TAT706-AE6M
Reference: TAT706-AE10Y, TAT706-AE10N, TAT706-AE20Y, TAT706-AE20N
EMDN: W0103020307
EMDN description: THROMBIN-ANTITHROMBIN III-COMPLEX
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 10:54

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TAC Tacrolimus(CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-TAC706-AEVH
Basic UDI-DI: B-TAC706-AEVH
Reference: TAC706-AE10Y, TAC706-AE10N, TAC706-AE20Y, TAC706-AE20N
EMDN: W0102080603
EMDN description: TACROLIMUS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 10:54

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T4 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-T4-D06aLA
Basic UDI-DI: B-T4-D06aLA
Reference: T4-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: 15.07.2026 10:53

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T3 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-T3-D06aKV
Basic UDI-DI: B-T3-D06aKV
Reference: T3-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: 15.07.2026 10:53

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Syphilis 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-SYP-D02aVJ
Basic UDI-DI: B-SYP-D02aVJ
Reference: SYP-D02a, SYP-D01a
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 10:46

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Salmonella typhi & Salmonellaparatyphi 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-STYS-K02a2U
Basic UDI-DI: B-STYS-K02a2U
Reference: STYS-K02a
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 10:45

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Strep 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-STB-K02aNQ
Basic UDI-DI: B-STB-K02aNQ
Reference: STB-K02a
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 10:45

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Strep A 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-STA-B02bLE
Basic UDI-DI: B-STA-B02bLE
Reference: STA-B02b
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 15.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

ST2 Growth Stimulation Expressed gene 2 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-ST2706-AEXK
Basic UDI-DI: B-ST2706-AEXK
Reference: ST2706-AE10Y, ST2706-AE10N, ST2706-AE20Y, ST2706-AE20N
EMDN: W01021314
EMDN description: ST2
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 10:44

Manufacturer products Authorised representative products Authorised representative actors View details

ST2 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-ST2-D06aFG
Basic UDI-DI: B-ST2-D06aFG
Reference: ST2-D06a
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 15.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

SP-10 Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-SP10-K02aVR
Basic UDI-DI: B-SP10-K02aVR
Reference: SP10-K02a
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 06:56

Manufacturer products Authorised representative products Authorised representative actors View details

SOMA One Step Carisoprodol Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-SOMA-A01aFT
Basic UDI-DI: B-SOMA-A01aFT
Reference: SOMA-A01a, SOMA-A01b
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

SHBG Sex Hormone-Binding Globulin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-SHBG706-AE2D
Basic UDI-DI: B-SHBG706-AE2D
Reference: SHBG706-AE10Y, SHBG706-AE10N, SHBG706-AE20Y, SHBG706-AE20N
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 06:29

Manufacturer products Authorised representative products Authorised representative actors View details

SCC Squamous Cell Carcinoma Antigen (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-SCC706-AEVY
Basic UDI-DI: B-SCC706-AEVY
Reference: SCC706-AE
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:39

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgG/IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-SC2GMAb801B9
Basic UDI-DI: B-SC2GMAb801B9
Reference: SC2GMAb801
EMDN: W0105090502
EMDN description: CORONAVIRUS ANTIBODY (AB) - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:39

Manufacturer products Authorised representative products Authorised representative actors View details