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406 device results listed.

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CK-MB Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDCKM-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GDCKM-402aHGUQ
Basic UDI-DI: B-GDCKM-402aHGUQ
Reference: GDCKM-402a
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

One Step CK-MB Test Cassette (Serum/Plasma)

GDCKM-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDCKM-302aWP
Basic UDI-DI: B-GDCKM-302aWP
Reference: GDCKM-302a
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

One Step CK-MB Test Cassette (Serum/Plasma)

GDCKM-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GDCKM-302aHGUB
Basic UDI-DI: B-GDCKM-302aHGUB
Reference: GDCKM-302a
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDCAR-W435a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GDCAR-W435aHGDL
Basic UDI-DI: B-GDCAR-W435aHGDL
Reference: GDCAR-W435a
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDCAR-W435a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDCAR-W435a2C
Basic UDI-DI: B-GDCAR-W435a2C
Reference: GDCAR-W435a
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin/CK-MB/Troponin I Combo Test Cassette (Serum/Plasma)

GDCAR-335a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDCAR-335aU6
Basic UDI-DI: B-GDCAR-335aU6
Reference: Myoglobin/CK-MB/Troponin I Combo Test Cassette (Serum/Plasma)
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin/CK-MB/Troponin I Combo Test Cassette (Serum/Plasma)

GDCAR-335a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GDCAR-335aHGRS
Basic UDI-DI: B-GDCAR-335aHGRS
Reference: GDCAR-335a
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-FI-SNBNP-4028N

High-Sensitivity NT-proBNP Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-SNBNP-4028N
Basic UDI-DI: B-FI-SNBNP-4028N
Reference: High-Sensitivity NT-proBNP Test Cassette
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

High-Sensitivity Cardiac Troponin T Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-SCTT-4023J
Basic UDI-DI: B-FI-SCTT-4023J
Reference: FI-SCTT-402
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4103204EG

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-EIM4103204EG
Basic UDI-DI: B-EIM4103204EG
Reference: EIM4103204
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-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