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581 device results listed.

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IL-6 Control

FDIL6-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDIL6-PN20HG2Y
Basic UDI-DI: B-FDIL6-PN20HG2Y
Reference: FDIL6-PN20
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
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

IL-6 Quantitative Test Kit (Time-Resolved FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDIL6-402aHGLN
Basic UDI-DI: B-FDIL6-402aHGLN
Reference: FDIL6-402a
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
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

D-Dimer Control

FDDDI-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDDDI-PN20HG3D
Basic UDI-DI: B-FDDDI-PN20HG3D
Reference: FDDDI-PN20
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
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 Quantitative Test Kit (Time-Resolved FIA)

FDDDI-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDDDI-402aHGM3
Basic UDI-DI: B-FDDDI-402aHGM3
Reference: FDDDI-402a
EMDN: W0103020503
EMDN description: D-DIMER
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 Control

FDDCB-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDDCB-PN20HGWE
Basic UDI-DI: B-FDDCB-PN20HGWE
Reference: FDDCB-PN20
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
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

CT Control

FDCT-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDCT-PN20HG3Q
Basic UDI-DI: B-FDCT-PN20HG3Q
Reference: FDCT-PN20
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
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

CRP / SAA Quantitative Test Kit (Time-Resolved FIA)

FDCS-T402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDCS-T402aHG37
Basic UDI-DI: B-FDCS-T402aHG37
Reference: FDCS-T402a
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - 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

CRP/SAA Control

FDCS-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDCS-PN20HG35
Basic UDI-DI: B-FDCS-PN20HG35
Reference: FDCS-PN20
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
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 Control

FDCKM-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDCKM-PN20HG9V
Basic UDI-DI: B-FDCKM-PN20HG9V
Reference: FDCKM-PN20
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
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

cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)

FDCAR-T402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDCAR-T402aHG92
Basic UDI-DI: B-FDCAR-T402aHG92
Reference: FDCAR-T402a
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
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

cTnl/ Myo/ CK-MB Control

FDCAR-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDCAR-PN20HG5N
Basic UDI-DI: B-FDCAR-PN20HG5N
Reference: FDCAR-PN20
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
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

Cardiac Markers Control

FDCAR-LP3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDCAR-LP3HG3V
Basic UDI-DI: B-FDCAR-LP3HG3V
Reference: FDCAR-LP3
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
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

Calprotectin Quantitative Test Kit (Time-Resolved FIA)

FDCAL-602a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDCAL-602aHGLL
Basic UDI-DI: B-FDCAL-602aHGLL
Reference: FDCAL-602a
EMDN: W0102019009
EMDN description: CALPROTECTIN
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 Control

FDBNP-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDBNP-PN20HGCW
Basic UDI-DI: B-FDBNP-PN20HGCW
Reference: FDBNP-PN20
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
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 Control

FDBNA-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDBNA-PN20HG3Z
Basic UDI-DI: B-FDBNA-PN20HG3Z
Reference: FDBNA-PN20
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
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

RSV Antigen FIA Control Kit

FCRSV-PN2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FCRSV-PN2HGTC
Basic UDI-DI: B-FCRSV-PN2HGTC
Reference: FCRSV-PN2
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details