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CRP Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983188722
Basic UDI-DI: B-06936983188722
Reference: CCR-402
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 01:56

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™

VMPO04EP

IVD Class CIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250155
Basic UDI-DI: 868354825VMPO04EPNG
Reference: VMPO04EP
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 01:47

Manufacturer products View details

RapidFor™

VMPO46EP

IVD Class CIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250841
Basic UDI-DI: 868354825VMPO46EPPN
Reference: VMPO46EP
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 01:46

Manufacturer products View details

Dimension EXL LOCI Module Cardiac Troponin I (TNI) Flex reagent cartridge

DX_LS_LEGACY_00842768022067

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768022067
Basic UDI-DI: B-00842768022067
Reference: 10464525
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 23:23

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I (cTnI) Rapid Test Kit (QDs Immunofluorescence Method)

cTnI-QD Test

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Chongqing iSIA BIO-Technology Co., Ltd.
Manufacturer SRN: CN-MF-000003364
UDI-DI: 26974969790167
Basic UDI-DI: 69749697901002DR
Reference: 02W cTnI
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.09.2026 21:41

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I (cTnI) Rapid Test Kit (QDs Immunofluorescence Method)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Chongqing iSIA BIO-Technology Co., Ltd.
Manufacturer SRN: CN-MF-000003364
UDI-DI: 36974969790164
Basic UDI-DI: 69749697901002DR
Reference: 02W cTnI
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.09.2026 21:02

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine kinase-MB (CK-MB) Test Kit (Homogeneous Chemiluminescence Immunoassay)

Creatine kinase-MB (CK-MB)Test Kit (Homogeneous Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524061585
Basic UDI-DI: B-06974524061585
Reference: HCLIA15125
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 21.09.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB AccuBind ELISA Kit - 192 wells

2925-300B

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020662
Basic UDI-DI: B-00816870020662
Reference: 2925-300B
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 21.09.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB AccuBind ELISA Kit - 96 wells

2925-300A

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020655
Basic UDI-DI: B-00816870020655
Reference: 2925-300A
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 21.09.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB AccuLite CLIA Kit - 192 wells

2975-300B

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870022345
Basic UDI-DI: B-00816870022345
Reference: 2975-300B
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 21.09.2026 18:39

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB AccuLite CLIA Kit - 96 wells

2975-300A

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870022338
Basic UDI-DI: B-00816870022338
Reference: 2975-300A
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 21.09.2026 18:39

Manufacturer products Authorised representative products Authorised representative actors View details

hs-CRP+CRP Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414736731
Basic UDI-DI: B-06954414736731
Reference: IF8003
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.09.2026 17:53

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I (cTnI) Test Kit (Immunofluorescence)

25 Tests /Box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nanjing Norman Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000024233
UDI-DI: 06921893001490
Basic UDI-DI: B-06921893001490
Reference: 22401710500140
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Bulgaria
Authorised representative: Sungo Cert GmbH
Last updated: 12.08.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Myocardial Infarction (MI) 3-in-1 (cTnI/CK-MB/MYO) Test Kit (Immunofluorescence)

25 Tests /Box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nanjing Norman Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000024233
UDI-DI: 06921893001483
Basic UDI-DI: B-06921893001483
Reference: 22401910500020
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Bulgaria
Authorised representative: Sungo Cert GmbH
Last updated: 12.08.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

N-terminal pro B-type natriuretic peptide (NT-proBNP) Test Kit (Immunofluorescence)

25 Tests /Box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nanjing Norman Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000024233
UDI-DI: 06921893001469
Basic UDI-DI: B-06921893001469
Reference: 22400310500080
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Bulgaria
Authorised representative: Sungo Cert GmbH
Last updated: 12.08.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

NT-proBNP Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: D-300040BUV
Basic UDI-DI: B-300040BUV
Reference: HU-RE-F07F061001
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: D-300039BVK
Basic UDI-DI: B-300039BVK
Reference: HU-RE-F07F044001
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: D-300022BUR
Basic UDI-DI: B-300022BUR
Reference: HU-RE-F07F034001
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Rapid Quantitative Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490428
Basic UDI-DI: B-06975679490428
Reference: HU-RE-F07F044002
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Access BNP II

D06227

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590805678
Basic UDI-DI: 150995901BNPIIBE
Reference: D24688
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details