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639 device results listed.

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HbA1c Quantitative Test Kit (Time-Resolved FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FIHBA-402aSW
Basic UDI-DI: B-FIHBA-402aSW
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: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FIFA-LP3FE
Basic UDI-DI: B-FIFA-LP3FE
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 marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FIFA-302aUC
Basic UDI-DI: B-FIFA-302aUC
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: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FICYS-PN20KB
Basic UDI-DI: B-FICYS-PN20KB
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: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FICYS-402aBK
Basic UDI-DI: B-FICYS-402aBK
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 testingReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FGIGE-302aW5
Basic UDI-DI: B-FGIGE-302aW5
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: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FEPRL-PN20HL
Basic UDI-DI: B-FEPRL-PN20HL
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: 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

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

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

FERR Control

FEFER-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FEFER-PN2077
Basic UDI-DI: B-FEFER-PN2077
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: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FEFER-402aXC
Basic UDI-DI: B-FEFER-402aXC
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: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FECEA-PN20WE
Basic UDI-DI: B-FECEA-PN20WE
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 marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

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

AFP Control

FEAFP-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FEAFP-PN203X
Basic UDI-DI: B-FEAFP-PN203X
Reference: FEAFP-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

AFP Quantitative Test Kit (Time-Resolved FIA)

FEAFP-302a

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FEAFP-302aTV
Basic UDI-DI: B-FEAFP-302aTV
Reference: FEAFP-302a
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
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

CRP Quantitative Test Kit (Time-Resolved FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDWCR-402a7R
Basic UDI-DI: B-FDWCR-402a7R
Reference: FDWCR-402a
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
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

cTnI Control

FDTRO-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDTRO-PN20LG
Basic UDI-DI: B-FDTRO-PN20LG
Reference: FDTRO-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 21:23

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