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AURYX 90 CK-MB Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514600557
Basic UDI-DI: B-05907514600557
Reference: I20-R0031
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 00:52

Manufacturer products View details

Cardiac Troponin I (cTnI)

346

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100691
Basic UDI-DI: B-05404035100691
Reference: 346
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:34

Manufacturer products View details

04560189212909

AIA-PACK BNP CONTROL SET

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189212909
Basic UDI-DI: B-04560189212909
Reference: 0025428
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

04560189212893

ST AIA-PACK BNP SAMPLE DILUTING SOLUTION

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189212893
Basic UDI-DI: B-04560189212893
Reference: 0025528
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

04560189212886

ST AIA-PACK BNP CALIBRATOR SET

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189212886
Basic UDI-DI: B-04560189212886
Reference: 0025328
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

04560189212879

ST AIA-PACK BNP

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189212879
Basic UDI-DI: B-04560189212879
Reference: 0025228
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

04560189211063

ST AIA-PACK cTnI 3rd-Gen SAMPLE DILUTING SOLUTION

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189211063
Basic UDI-DI: B-04560189211063
Reference: 0025515
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

04560189211056

ST AIA-PACK cTnI 3rd-Gen CALIBRATOR SET

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189211056
Basic UDI-DI: B-04560189211056
Reference: 0025315
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

04560189211025

ST AIA-PACK Myoglobin SAMPLE DILUTING SOLUTION

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189211025
Basic UDI-DI: B-04560189211025
Reference: 0025597
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

04560189211018

ST AIA-PACK Myoglobin CALIBRATOR SET

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189211018
Basic UDI-DI: B-04560189211018
Reference: 0025397
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

In vitro Diagnostic Kit for Myoglobin (Chemiluminescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656863
Basic UDI-DI: B-00810173656863
Reference: 1MYOB02
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

In vitro Diagnostic Kit for Myoglobin (Chemiluminescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656856
Basic UDI-DI: B-00810173656856
Reference: 1MYOB01
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656849
Basic UDI-DI: B-00810173656849
Reference: 1CTNTB02
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656832
Basic UDI-DI: B-00810173656832
Reference: 1CTNTB01
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

++B261CANCRP4360XQ

96 Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Diagnostics Biochem Canada Inc.
Manufacturer SRN: CA-MF-000032449
UDI-DI: ++B261CANCRP4360XQ
Basic UDI-DI: B-++B261CANCRP4360XQ
Reference: CAN-CRP-4360
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 01.08.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

Alinity c Myoglobin Reagent Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08436003070962
Basic UDI-DI: 8436003070498Y7
Reference: 01R1523
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:43

Manufacturer products View details

Quantia Myoglobin

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08436003070955
Basic UDI-DI: 8436003070511X6
Reference: 6L32-44
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:43

Manufacturer products View details

High Sensitive Troponin T test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700408997
Basic UDI-DI: 697029753465M2
Reference: HGCL75
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

B-type Natriuretic Peptide test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700406658
Basic UDI-DI: 697029753291LR
Reference: HGCL67
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

N-terminal Pro-B-type Natriuretic Peptide rapid test (Colloidal Gold)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403435
Basic UDI-DI: 697029753311L6
Reference: HGCG01
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details