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416 device results listed.

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D-EIM4102204E9

N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4102204E9
Basic UDI-DI: B-EIM4102204E9
Reference: EIM4102204
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4101204E2

N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4101204E2
Basic UDI-DI: B-EIM4101204E2
Reference: EIM4101204
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

cTnT 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-CTNT-D06aGN
Basic UDI-DI: B-CTNT-D06aGN
Reference: CTNT-D06a
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 13:35

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI 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-CTNI-D06aC7
Basic UDI-DI: B-CTNI-D06aC7
Reference: CTNI-D06a
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 13:34

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CTNI-D02aBT
Basic UDI-DI: B-CTNI-D02aBT
Reference: CTNI-D02a
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 13:34

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S071RN

BF S07

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S071RN
Basic UDI-DI: B-CNMF000014455-BF-S071RN
Reference: BF-S071
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-CMC-W23SG

Cardiac Marker Rapid Test device and Immunoassay Reader

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: D-CMC-W23SG
Basic UDI-DI: B-CMC-W23SG
Reference: CMC-W23
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 05:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-CMC-W23FBK

Cardiac Marker Combo Rapid Test Device and Fluorescent Immunoassay Reader

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: D-CMC-W23FBK
Basic UDI-DI: B-CMC-W23FBK
Reference: CMC-W23F
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 05:08

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI/CK-MB/MYO 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-CMC-D06a8R
Basic UDI-DI: B-CMC-D06a8R
Reference: CMC-D06a
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 05:08

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB 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-CK-MB-D06aL4
Basic UDI-DI: B-CK-MB-D06aL4
Reference: CK-MB-D06a
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

BNP 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-BNP-D26aEA
Basic UDI-DI: B-BNP-D26aEA
Reference: BNP-D26a
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 03:28

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® Myoglobin Strip (Whole Blood/Serum/Plasma)

Strip

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-CT-A68SV
Basic UDI-DI: B-ABT-CT-A68SV
Reference: ABT-CT-A68
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® CK-MB Strip (Whole Blood/Serum/Plasma)

Strip

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-CT-A66SR
Basic UDI-DI: B-ABT-CT-A66SR
Reference: ABT-CT-A66
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® CRP Test Semi-Quantitative Strip (Whole Blood/Serum/Plasma)

Strip

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-CT-A251LS
Basic UDI-DI: B-ABT-CT-A251LS
Reference: ABT-CT-A251
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® NT-proBNP Strip (Whole Blood/Serum/Plasma)

Strip

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-CT-A111L9
Basic UDI-DI: B-ABT-CT-A111L9
Reference: ABT-CT-A111
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Injury Marker Test Device (Serum/plasma/whole blood)

CAR0239

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610337
Basic UDI-DI: B-86979834610337
Reference: CAR0239
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-808171QK

cTnI/DD/BNP Rapid Detect

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808171QK
Basic UDI-DI: B-808171QK
Reference: 808171
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-808170QH

BNP Rapid Detect

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808170QH
Basic UDI-DI: B-808170QH
Reference: 808170
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-808169QY

CK-MB Rapid Detect

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808169QY
Basic UDI-DI: B-808169QY
Reference: 808169
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-808168QW

MYO Rapid Detect

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808168QW
Basic UDI-DI: B-808168QW
Reference: 808168
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:55

Manufacturer products Authorised representative products Authorised representative actors View details