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458 device results listed.

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D-IM4105202GS

Cardiac Troponin I (cTnI) 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-IM4105202GS
Basic UDI-DI: B-IM4105202GS
Reference: IM4105202
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4105201GQ

Creatine Kinase Isoenzyme MB (CK-MB) 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-IM4105201GQ
Basic UDI-DI: B-IM4105201GQ
Reference: IM4105201
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4104203GM

Myoglobin (MYO) Assay Kit by Fluorescence Immunochromatographic Metho

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4104203GM
Basic UDI-DI: B-IM4104203GM
Reference: IM4104203
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4104202GK

Cardiac Troponin I (cTnI) 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-IM4104202GK
Basic UDI-DI: B-IM4104202GK
Reference: IM4104202
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4104201GH

Creatine Kinase Isoenzyme MB (CK-MB) 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-IM4104201GH
Basic UDI-DI: B-IM4104201GH
Reference: IM4104201
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-HFABP-W23F3ZP

H-FABP FIA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: D-HFABP-W23F3ZP
Basic UDI-DI: B-HFABP-W23F3ZP
Reference: H-FABP-W23F3
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 00:54

Manufacturer products Authorised representative products Authorised representative actors View details

H-FABP 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-H-FABP-D06aBK
Basic UDI-DI: B-H-FABP-D06aBK
Reference: H-FABP-D06a
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 00:44

Manufacturer products Authorised representative products Authorised representative actors View details

PCT / IL-6 Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD164XQ
Basic UDI-DI: B-GKPD164XQ
Reference: GKPD164
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

PCT/IL—6/CRP Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD163XN
Basic UDI-DI: B-GKPD163XN
Reference: GKPD163
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

CRP/ SAA Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD162XL
Basic UDI-DI: B-GKPD162XL
Reference: GKPD162
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI / Myo / CK-MB Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD161XJ
Basic UDI-DI: B-GKPD161XJ
Reference: GKPD161
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI / Myoglobin / CK-MB Triplex Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD134XF
Basic UDI-DI: B-GKPD134XF
Reference: GKPD134
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD133XD
Basic UDI-DI: B-GKPD133XD
Reference: GKPD133
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDTRO-402d

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GDTRO-402dHGJW
Basic UDI-DI: B-GDTRO-402dHGJW
Reference: GDTRO-402d
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDTRO-402d

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDTRO-402dDT
Basic UDI-DI: B-GDTRO-402dDT
Reference: GDTRO-402d
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

"Troponin I Rapid Test Cassette (Whole Blood/ Serum/Plasma)"

GDTRO-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GDTRO-402bHGJL
Basic UDI-DI: B-GDTRO-402bHGJL
Reference: GDTRO-402b
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDTRO-402b

IVD generalIVDDOn the marketInstrumentKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDTRO-402bDP
Basic UDI-DI: B-GDTRO-402bDP
Reference: GDTRO-402b
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 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDTRO-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GDTRO-402aHGJF
Basic UDI-DI: B-GDTRO-402aHGJF
Reference: GDTRO-402a
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDTRO-402a

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDTRO-402aDM
Basic UDI-DI: B-GDTRO-402aDM
Reference: GDTRO-402a
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 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I Rapid Test Cassette (Serum/Plasma)

GDTRO-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GDTRO-302aHGJ2
Basic UDI-DI: B-GDTRO-302aHGJ2
Reference: GDTRO-302a
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details