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639 device results listed.

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Free T4 Quantitative Test Kit (Time-Resolved FIA)

FKFT4-302a

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FKFT4-302aXM
Basic UDI-DI: B-FKFT4-302aXM
Reference: FKFT4-302a
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

fT3 Control

FKFT3-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FKFT3-PN207A
Basic UDI-DI: B-FKFT3-PN207A
Reference: FKFT3-PN20
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

Free T3 Quantitative Test Kit (Time-Resolved FIA)

FKFT3-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FKFT3-402aXF
Basic UDI-DI: B-FKFT3-402aXF
Reference: FKFT3-402a
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

Free T3 Quantitative Test Kit (Time-Resolved FIA)

FKFT3-302a

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FKFT3-302aX8
Basic UDI-DI: B-FKFT3-302aX8
Reference: FKFT3-302a
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

Cortisol Control

FKCOR-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FKCOR-PN20F2
Basic UDI-DI: B-FKCOR-PN20F2
Reference: FKCOR-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 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

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: 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

25-OH-VD Control

FIVD-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FIVD-PN20E5
Basic UDI-DI: B-FIVD-PN20E5
Reference: FIVD-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 21:33

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

VB12 Control

FIVB12-LP3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FIVB12-LP3ZR
Basic UDI-DI: B-FIVB12-LP3ZR
Reference: FIVB12-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 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin B12 Quantitative Test Kit (Time-Resolved FIA)

FIVB12-302a

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FIVB12-302aN2
Basic UDI-DI: B-FIVB12-302aN2
Reference: FIVB12-302a
EMDN: W0102070204
EMDN description: VITAMIN B12
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

TSH Control

FITSH-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FITSH-PN20MR
Basic UDI-DI: B-FITSH-PN20MR
Reference: FITSH-PN20
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:33

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 Control

FINGA-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FINGA-PN208Y
Basic UDI-DI: B-FINGA-PN208Y
Reference: FINGA-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 21:33

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

Beta2-MG Control

FIMG-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FIMG-PN20AK
Basic UDI-DI: B-FIMG-PN20AK
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: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FIMG-402a2T
Basic UDI-DI: B-FIMG-402a2T
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: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FIMAU-PN20DB
Basic UDI-DI: B-FIMAU-PN20DB
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: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FIHSA-102a3D
Basic UDI-DI: B-FIHSA-102a3D
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 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Control

FIHBA-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FIHBA-PN202R
Basic UDI-DI: B-FIHBA-PN202R
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