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Cortisol Quantitative Test Kit (Time-Resolved FIA)

FKCOR-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FKCOR-402a7A
Basic UDI-DI: B-FKCOR-402a7A
Reference: FKCOR-402a
EMDN: W0102060203
EMDN description: CORTISOL
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

Cortisol Quantitative Test Kit (Time-Resolved FIA)

FKCOR-302a

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FKCOR-302aHG7V
Basic UDI-DI: B-FKCOR-302aHG7V
Reference: FKCOR-302a
EMDN: W0102060203
EMDN description: CORTISOL
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

Cortisol Quantitative Test Kit (Time-Resolved FIA)

FKCOR-302a

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FKCOR-302a73
Basic UDI-DI: B-FKCOR-302a73
Reference: FKCOR-302a
EMDN: W0102060203
EMDN description: CORTISOL
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

Vitamin D Quantitative Test Kit (Time-Resolved FIA)

FIVD-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FIVD-402aHGW4
Basic UDI-DI: B-FIVD-402aHGW4
Reference: FIVD-402a
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
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

Vitamin D Quantitative Test Kit (Time-Resolved FIA)

FIVD-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FIVD-402a6D
Basic UDI-DI: B-FIVD-402a6D
Reference: FIVD-402a
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
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

S100-β Quantitative Test Kit (Time-Resolved FIA)

FIS100-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FIS100-402aHG6H
Basic UDI-DI: B-FIS100-402aHG6H
Reference: FIS100-402a
EMDN: W0102060599
EMDN description: NEOENDOCRINE FUNCTION ASSAYS - OTHER
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

S100-β Quantitative Test Kit (Time-Resolved FIA)

FIS100-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FIS100-402a99
Basic UDI-DI: B-FIS100-402a99
Reference: FIS100-402a
EMDN: W0102060599
EMDN description: NEOENDOCRINE FUNCTION ASSAYS - OTHER
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

NGAL Quantitative Test Kit (Time-Resolved FIA)

FINGA-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FINGA-402aZ5
Basic UDI-DI: B-FINGA-402aZ5
Reference: FINGA-402a
EMDN: W0102060207
EMDN description: NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)
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

NGAL Quantitative Test Kit (Time-Resolved FIA)

FINGA-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FINGA-402aHGYD
Basic UDI-DI: B-FINGA-402aHGYD
Reference: FINGA-402a
EMDN: W0102060207
EMDN description: NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)
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

PGII Quantitative Test Kit (Time-Resolved FIA)

FEPG(II)-302a-G16

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FEPG(II)-302a-G16VM
Basic UDI-DI: B-FEPG(II)-302a-G16VM
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

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 marketCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FEPG(I)-302a-G16VS
Basic UDI-DI: B-FEPG(I)-302a-G16VS
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

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: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FEG17-302a-G16VT
Basic UDI-DI: B-FEG17-302a-G16VT
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

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

Calcitonin Quantitative Test Kit (Time-Resolved FIA)

FECAL-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FECAL-402aQZ
Basic UDI-DI: B-FECAL-402aQZ
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

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

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

FDPI-T402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDPI-T402aHG7S
Basic UDI-DI: B-FDPI-T402aHG7S
Reference: FDPI-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 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

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

FDPI-T402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDPI-T402a58
Basic UDI-DI: B-FDPI-T402a58
Reference: FDPI-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 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Quantitative Test Kit (Time-Resolved FIA)

FDPCT-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDPCT-402aHG5U
Basic UDI-DI: B-FDPCT-402aHG5U
Reference: FDPCT-402a
EMDN: W0102069013
EMDN description: PROCALCITONIN
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