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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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03.08.2026 18:01

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INNODX NSE CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-NSE-01100C6M
Basic UDI-DI: B-KR-NSE-01100C6M
Reference: KR-NSE-01100C
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX LN CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-LN-01100CJK
Basic UDI-DI: B-KR-LN-01100CJK
Reference: KR-LN-01100C
EMDN: W0102039006
EMDN description: LAMININ
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX HE4 CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-HE4-01100CDJ
Basic UDI-DI: B-KR-HE4-01100CDJ
Reference: KR-HE4-01100C
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:43

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX Cy21-1 CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-Cy21-1-01100CT6
Basic UDI-DI: B-KR-Cy21-1-01100CT6
Reference: KR-Cy21-1-01100C
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX CEA CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-CEA-01100CG5
Basic UDI-DI: B-KR-CEA-01100CG5
Reference: KR-CEA-01100C
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX CA72-4 CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-CA72-4-01100C7M
Basic UDI-DI: B-KR-CA72-4-01100C7M
Reference: KR-CA72-4-01100C
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX CA50 CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-CA50-01100C28
Basic UDI-DI: B-KR-CA50-01100C28
Reference: KR-CA50-01100C
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX CA242 CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-CA242-01100CYW
Basic UDI-DI: B-KR-CA242-01100CYW
Reference: KR-CA242-01100C
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX CA19-9 CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-CA19-9-01100CB5
Basic UDI-DI: B-KR-CA19-9-01100CB5
Reference: KR-CA19-9-01100C
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX CA15-3 CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-CA15-3-01100C3X
Basic UDI-DI: B-KR-CA15-3-01100C3X
Reference: KR-CA15-3-01100C
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX CA125 CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-CA125-01100CYC
Basic UDI-DI: B-KR-CA125-01100CYC
Reference: KR-CA125-01100C
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX ß2-MG CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-B2-MG-01100CAV
Basic UDI-DI: B-KR-B2-MG-01100CAV
Reference: KR-β2-MG-01100C
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:40

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX AFP CMIA

KR-AFP-01100C

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-AFP-01100CPX
Basic UDI-DI: B-KR-AFP-01100CPX
Reference: KR-AFP-01100C
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:40

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-040P9

Beta 2 microglobulin (β2-MG) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-040P9
Basic UDI-DI: B-K90411-040P9
Reference: /
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-034PE

Carcinoembryonic antigen (CEA) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-034PE
Basic UDI-DI: B-K90411-034PE
Reference: /
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-032PA

Alpha-fetoprotein (AFP) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-032PA
Basic UDI-DI: B-K90411-032PA
Reference: /
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-029PM

Progesterone (PROG) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-029PM
Basic UDI-DI: B-K90411-029PM
Reference: /
EMDN: W0102030202
EMDN description: PROGESTERONE RECEPTOR ASSAYS
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-017PE

Beta 2 microglobulin (β2-MG) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-017PE
Basic UDI-DI: B-K90411-017PE
Reference: /
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4494129MC

PIVKA-II Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4494129MC
Basic UDI-DI: B-IM4494129MC
Reference: IM4494129
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4493129M5

PIVKA-II Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4493129M5
Basic UDI-DI: B-IM4493129M5
Reference: IM4493129
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details