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Access Myoglobin

973243

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231682
Basic UDI-DI: 150995901AccMyoUQ
Reference: 973243
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE 800 Immunochemistry Systems CCRP High Sensitivity Cardiac C-Reactive Protein Reagent

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590203160
Basic UDI-DI: 150995901A38656RN
Reference: A38656
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Homocysteine Flex reagent cartridge

IVDR_67_MAR EB_B_KIT_V_HCYS

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006128
Basic UDI-DI: 0405686900914VT
Reference: 10445897
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:25

Manufacturer products View details

High Sensitive Cardiac Troponin I (hs-cTnI) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334825159
Basic UDI-DI: B-06950334825159
Reference: 52026262
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 28.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity C-Reactive Protein (HS-CRP) Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334825050
Basic UDI-DI: B-06950334825050
Reference: 32027248
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 28.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin T（cTnT）Diagnostic Kit ( Immunochromatographic Assay)

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348761165
Basic UDI-DI: B-06971348761165
Reference: MF-84-20
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin (MyO) Diagnostic Kit

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762414
Basic UDI-DI: B-06971348762414
Reference: MF-33-25
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:53

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I (cTnI) Diagnostic Kit(Immunochromatographic Assay)

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762407
Basic UDI-DI: B-06971348762407
Reference: MF-31-25
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:53

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin (MyO) Diagnostic Kit

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760205
Basic UDI-DI: B-06971348760205
Reference: MF-33-20
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:52

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I (cTnI) Diagnostic Kit(Immunochromatographic Assay)

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760014
Basic UDI-DI: B-06971348760014
Reference: MF-31-20
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:51

Manufacturer products Authorised representative products Authorised representative actors View details

N Latex HCY

IVDR_27_MAR EB_B_KIT _N_La_HCY

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006715
Basic UDI-DI: 0405686900882W7
Reference: 10445973
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Germany
Authorised representative: -
Last updated: 23.07.2026 03:19

Manufacturer products View details

08800111723124

i-NTP-01

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723124
Basic UDI-DI: 88001117IPCA01IA06WN
Reference: 16NTP10D
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 22.07.2026 23:24

Manufacturer products Authorised representative products Authorised representative actors View details

08800111723148

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723148
Basic UDI-DI: 88001117IPCA01IA06WN
Reference: 16NTP10Q
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 22.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-R224152C

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R224152C
Basic UDI-DI: B-R224152C
Reference: R22415
EMDN: W01021312
EMDN description: LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-R224142A

30 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R224142A
Basic UDI-DI: B-R224142A
Reference: R22414
EMDN: W01021312
EMDN description: LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-R2241328

200 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R2241328
Basic UDI-DI: B-R2241328
Reference: R22413
EMDN: W01021312
EMDN description: LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-R2241226

100 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R2241226
Basic UDI-DI: B-R2241226
Reference: R22412
EMDN: W01021312
EMDN description: LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-R2241124

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R2241124
Basic UDI-DI: B-R2241124
Reference: R22411
EMDN: W01021312
EMDN description: LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-R1521328

200 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R1521328
Basic UDI-DI: B-R1521328
Reference: R15213
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:03

Manufacturer products Authorised representative products Authorised representative actors View details

D-R1521226

100 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R1521226
Basic UDI-DI: B-R1521226
Reference: R15212
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:03

Manufacturer products Authorised representative products Authorised representative actors View details