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581 device results listed.

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Beta2-MG Control

FIMG-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FIMG-PN20HG7Q
Basic UDI-DI: B-FIMG-PN20HG7Q
Reference: FIMG-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 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

β2-MG Quantitative Test Kit (Time-Resolved FIA)

FIMG-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FIMG-402aHGRE
Basic UDI-DI: B-FIMG-402aHGRE
Reference: FIMG-402a
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

MAU Control

FIMAU-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FIMAU-PN20HGMC
Basic UDI-DI: B-FIMAU-PN20HGMC
Reference: FIMAU-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 21:29

Manufacturer products Authorised representative products Authorised representative actors View details

MAU Quantitative Test Kit (Time-Resolved FIA)

FIHSA-102a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FIHSA-102aHG2F
Basic UDI-DI: B-FIHSA-102aHG2F
Reference: FIHSA-102a
EMDN: W0101060201
EMDN description: URINE SINGLE TEST STRIPS (INCL. TABLETS)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:29

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Control

FIHBA-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FIHBA-PN20HG5N
Basic UDI-DI: B-FIHBA-PN20HG5N
Reference: FIHBA-PN20
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Quantitative Test Kit (Time-Resolved FIA)

FIHBA-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FIHBA-402aHGPC
Basic UDI-DI: B-FIHBA-402aHGPC
Reference: FIHBA-402a
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

FA Control

FIFA-LP3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FIFA-LP3HG2W
Basic UDI-DI: B-FIFA-LP3HG2W
Reference: FIFA-LP3
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

Folic Acid (FA) Quantitative Test Kit (Time-Resolved FIA)

FIFA-302a

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FIFA-302aHGGE
Basic UDI-DI: B-FIFA-302aHGGE
Reference: FIFA-302a
EMDN: W0102070103
EMDN description: FOLATE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

CysC Control

FICYS-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FICYS-PN20HGUC
Basic UDI-DI: B-FICYS-PN20HGUC
Reference: FICYS-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 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

CysC Quantitative Test Kit (Time-Resolved FIA)

FICYS-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FICYS-402aHGE5
Basic UDI-DI: B-FICYS-402aHGE5
Reference: FICYS-402a
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

IgE Quantitative Test Kit(Time-Resolved FIA)

FGIGE-302a

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FGIGE-302aHGTV
Basic UDI-DI: B-FGIGE-302aHGTV
Reference: FGIGE-302a
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

PRL Control

FEPRL-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FEPRL-PN20HGT3
Basic UDI-DI: B-FEPRL-PN20HGT3
Reference: FEPRL-PN20
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

PGII Quantitative Test Kit (Time-Resolved FIA)

FEPG(II)-302a-G16

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FEPG(II)-302a-G16HG7W
Basic UDI-DI: B-FEPG(II)-302a-G16HG7W
Reference: FEPG(II)-302a-G16
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

PGI Quantitative Test Kit (Time-Resolved FIA)

FEPG(I)-302a-G16

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FEPG(I)-302a-G16HGW2
Basic UDI-DI: B-FEPG(I)-302a-G16HGW2
Reference: FEPG(I)-302a-G16
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

G-17 Quantitative Test Kit (Time-Resolved FIA)

FEG17-302a-G16

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FEG17-302a-G16HG7M
Basic UDI-DI: B-FEG17-302a-G16HG7M
Reference: FEG17-302a-G16
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

FERR Control

FEFER-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FEFER-PN20HGC8
Basic UDI-DI: B-FEFER-PN20HGC8
Reference: FEFER-PN20
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Ferritin Quantitative Test Kit (Time-Resolved FIA)

FEFER-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FEFER-402aHGVW
Basic UDI-DI: B-FEFER-402aHGVW
Reference: FEFER-402a
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Control

FECEA-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FECEA-PN20HGXB
Basic UDI-DI: B-FECEA-PN20HGXB
Reference: FECEA-PN20
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Quantitative Test Kit (Time-Resolved FIA)

FECEA-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FECEA-402aHGH4
Basic UDI-DI: B-FECEA-402aHGH4
Reference: FECEA-402a
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Calcitonin Quantitative Test Kit (Time-Resolved FIA)

FECAL-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FECAL-402aHGLR
Basic UDI-DI: B-FECAL-402aHGLR
Reference: FECAL-402a
EMDN: W0102060301
EMDN description: CALCITONIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details