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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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INNODX Hs-cTnT STAT CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-Hs-cTnTSTAT-0250J4
Basic UDI-DI: B-KR-Hs-cTnTSTAT-0250J4
Reference: KR-Hs-cTnT STAT-0250
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX CK-MB STAT CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-CK-MBSTAT-0250UF
Basic UDI-DI: B-KR-CK-MBSTAT-0250UF
Reference: KR-CK-MB STAT-0250
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX CK-MB STAT CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-CK-MBSTAT-02200ND
Basic UDI-DI: B-KR-CK-MBSTAT-02200ND
Reference: KR-CK-MB STAT-02200
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX CK-MB STAT CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-CK-MB-03100WP
Basic UDI-DI: B-KR-CK-MB-03100WP
Reference: KR-CK-MB-03100
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX BNP STAT CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-BNPSTAT-02506J
Basic UDI-DI: B-KR-BNPSTAT-02506J
Reference: KR-BNP STAT-0250
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX BNP STAT CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-BNPSTAT-02200WD
Basic UDI-DI: B-KR-BNPSTAT-02200WD
Reference: KR-BNP STAT-02200
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX BNP STAT CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-BNPSTAT-02100W8
Basic UDI-DI: B-KR-BNPSTAT-02100W8
Reference: KR-BNP STAT-02100
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX BNP STAT CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-BNPSTAT-01100VZ
Basic UDI-DI: B-KR-BNPSTAT-01100VZ
Reference: KR-BNP STAT-01100
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-K91201-0244

hs-CRP-BP, hs-CRP-BF

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K91201-0244
Basic UDI-DI: B-K91201-0244
Reference: /
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
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-K90411-046PM

Myeloperoxidase (MPO) 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-K90411-046PM
Basic UDI-DI: B-K90411-046PM
Reference: /
EMDN: W01021310
EMDN description: MYELOPEROXIDASE
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-K90411-041PB

Growth STimulation expressed gene 2 protein (ST2) 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-K90411-041PB
Basic UDI-DI: B-K90411-041PB
Reference: /
EMDN: W01021314
EMDN description: ST2
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-K90411-033PC

Heart type fatty acid binding protein (H-FABP) 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-K90411-033PC
Basic UDI-DI: B-K90411-033PC
Reference: /
EMDN: W01021302
EMDN description: HEART-TYPE FATTY ACID BINDING PROTEIN
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-K90411-024PB

Brain Natriuretic Peptides （BNP）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-K90411-024PB
Basic UDI-DI: B-K90411-024PB
Reference: /
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
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-K90411-023P9

Lipoprotein associated phospholipase A2 (Lp-PLA2) 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-K90411-023P9
Basic UDI-DI: B-K90411-023P9
Reference: /
EMDN: W01021312
EMDN description: LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2
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-K90411-020P3

Cardiac Troponin I & Creatine kinase Isoenzyme MB & Myoglobin Combo 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-K90411-020P3
Basic UDI-DI: B-K90411-020P3
Reference: /
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
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-K90411-018PG

N-terminal pro-B-type Natriuretic Peptide &Cardiac Troponin I Combo 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-K90411-018PG
Basic UDI-DI: B-K90411-018PG
Reference: /
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
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-K90411-008PD

Creatine kinase Isoenzyme MB(CK-MB) 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-K90411-008PD
Basic UDI-DI: B-K90411-008PD
Reference: /
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4495158MS

BNP Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4495158MS
Basic UDI-DI: B-IM4495158MS
Reference: IM4495158
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
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-IM4494158MK

BNP Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4494158MK
Basic UDI-DI: B-IM4494158MK
Reference: IM4494158
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
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-IM4493158MC

BNP Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4493158MC
Basic UDI-DI: B-IM4493158MC
Reference: IM4493158
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
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