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HCY Detection Kit (Immunofluorescence Chromatography)

HCY 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-GKPD193XX
Basic UDI-DI: B-GKPD193XX
Reference: GKPD193
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDMYO-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDMYO-402aD7
Basic UDI-DI: B-GDMYO-402aD7
Reference: GDMYO-402a
EMDN: W01021304
EMDN description: MYOGLOBIN
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

Atellica IM NT‑proBNPII (PBNPII)

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414284941
Basic UDI-DI: 0405686902296W2
Reference: 11203761
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

CardioPhase hsCRP

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768007736
Basic UDI-DI: 0405686900141UN
Reference: 10446091
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: -
Authorised representative: -
Last updated: 13.07.2026 22:55

Manufacturer products View details

Atellica IM High‑Sensitivity Troponin I (TnIH)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414006758
Basic UDI-DI: 0405686900809VV
Reference: 10997841
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI Quantitative Test Kit (Time-Resolved FIA)

FDTRO-402c

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDTRO-402cHGHL
Basic UDI-DI: B-FDTRO-402cHGHL
Reference: FDTRO-402c
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:23

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI Quantitative Test Kit (Time-Resolved FIA)

FDTRO-402c

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDTRO-402cCU
Basic UDI-DI: B-FDTRO-402cCU
Reference: FDTRO-402c
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Quantitative Test Kit (Time-Resolved FIA)

FDTRO-402b

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDTRO-402bHGHF
Basic UDI-DI: B-FDTRO-402bHGHF
Reference: FDTRO-402b
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Quantitative Test Kit (Time-Resolved FIA)

FDTRO-402b

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDTRO-402bCS
Basic UDI-DI: B-FDTRO-402bCS
Reference: FDTRO-402b
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

cTnT Quantitative Test Kit (Time-Resolved FIA)

FDTNT-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDTNT-402aHGHD
Basic UDI-DI: B-FDTNT-402aHGHD
Reference: FDTNT-402a
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

cTnT Quantitative Test Kit (Time-Resolved FIA)

FDTNT-

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDTNT-402aCM
Basic UDI-DI: B-FDTNT-402aCM
Reference: FDTNT-402a
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

Myo Quantitative Test Kit (Time-Resolved FIA)

FDMYO-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDMYO-402aHGFY
Basic UDI-DI: B-FDMYO-402aHGFY
Reference: FDMYO-402a
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

Myo Quantitative Test Kit (Time-Resolved FIA)

FDMYO-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDMYO-402aCA
Basic UDI-DI: B-FDMYO-402aCA
Reference: FDMYO-402a
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer/cTnI/NT-proBNP Quantitative Test Kit (Time-Resolved FIA)

FDDTB-425a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDDTB-425aXH
Basic UDI-DI: B-FDDTB-425aXH
Reference: FDDTB-425a
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer/cTnI/NT-proBNP Quantitative Test Kit (Time-Resolved FIA)

FDDTB-425a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDDTB-425aHGVR
Basic UDI-DI: B-FDDTB-425aHGVR
Reference: FDDTB-425a
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Quantitative Test Kit (Time-Resolved FIA)

FDCKM-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDCKM-402aVZ
Basic UDI-DI: B-FDCKM-402aVZ
Reference: FDCKM-402a
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Quantitative Test Kit (Time-Resolved FIA)

FDCKM-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDCKM-402aHGTK
Basic UDI-DI: B-FDCKM-402aHGTK
Reference: FDCKM-402a
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

NT-proBNP Quantitative Test Kit (Time-Resolved FIA)

FDBNP-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDBNP-402aY8
Basic UDI-DI: B-FDBNP-402aY8
Reference: FDBNP-402a
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

NT-proBNP Quantitative Test Kit (Time-Resolved FIA)

FDBNP-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDBNP-402aHGWL
Basic UDI-DI: B-FDBNP-402aHGWL
Reference: FDBNP-402a
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

BNP Quantitative Test Kit (Time-Resolved FIA)

FDBNA-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDBNA-402aS5
Basic UDI-DI: B-FDBNA-402aS5
Reference: FDBNA-402a
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details