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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

BNP Quantitative Test Kit (Time-Resolved FIA)

FDBNA-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDBNA-402aHGMP
Basic UDI-DI: B-FDBNA-402aHGMP
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

High Sensitive C-Reactive Protein (hs-CRP) Test Kit(Immunofluorescence)

50T/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0015Z5
Basic UDI-DI: B-FA0015Z5
Reference: 52027010
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Bulgaria
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

50T/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0014Z3
Basic UDI-DI: B-FA0014Z3
Reference: 52027001
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Bulgaria
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB (CK-MB) Test Kit(Immunofluorescence)

50T/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0012YX
Basic UDI-DI: B-FA0012YX
Reference: 52027009
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin (Myo) Test Kit (Immunofluorescence)

50T/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0011YV
Basic UDI-DI: B-FA0011YV
Reference: 52027003
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I (cTnI) Test Kit (Immunofluorescence)

50T/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0009ZA
Basic UDI-DI: B-FA0009ZA
Reference: 52027004
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Bulgaria
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

high sensitive C-reactive protein (hs-CRP) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4103076EX
Basic UDI-DI: B-EIM4103076EX
Reference: EIM4103076
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

high sensitive C-reactive protein (hs-CRP) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4102076EQ
Basic UDI-DI: B-EIM4102076EQ
Reference: EIM4102076
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

high sensitive C-reactive protein (hs-CRP) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4101076EH
Basic UDI-DI: B-EIM4101076EH
Reference: EIM4101076
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

high sensitivity C-reactive protein (hs-CRP)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01063115S
Basic UDI-DI: B-ECH01063115S
Reference: ECH0106311
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Isoenzyme MB（CK-MB）

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01062115M
Basic UDI-DI: B-ECH01062115M
Reference: ECH0106211
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

Homocysteine (Hcy)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01053515X
Basic UDI-DI: B-ECH01053515X
Reference: ECH0105351
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

high sensitivity C-reactive protein (hs-CRP)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01053115K
Basic UDI-DI: B-ECH01053115K
Reference: ECH0105311
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Isoenzyme MB（CK-MB）

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01052115E
Basic UDI-DI: B-ECH01052115E
Reference: ECH0105211
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details