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727 device results listed.

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Immunofluorescence Analyzer

OG-H180

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996021302
Basic UDI-DI: 69509960OG-H180N5
Reference: OG-H180
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 09.10.2026 02:11

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-channel Immunofluorescence Analyzer

OG-G260C

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996011273
Basic UDI-DI: 69509960OG-G260CS9
Reference: OG-G260C
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 09.10.2026 02:10

Manufacturer products Authorised representative products Authorised representative actors View details

Immunofluorescence Analyzer

OG-G200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996084680
Basic UDI-DI: 69509960OG-G200MB
Reference: OG-G200
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 09.10.2026 02:10

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25-OH-VD Quantitative Test Kit (Time-Resolved FIA)

FIVD-402a-DR10, FIVD-402a-DR10LH, FIVD-402a-DR10HG, FIVD-402a-DR, FIVD-402a-DRLH, FIVD-402a-DRHG

IVD Class BIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996096065
Basic UDI-DI: 69509960FIVD-402a-DRZ9
Reference: FIVD-402a-DRHG
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 09.10.2026 02:10

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HbA1c Quantitative Test Kit (Time-Resolved FIA)

FIHBA-402a-DR10, FIHBA-402a-DR10LH, FIHBA-402a-DR10HG, FIHBA-402a-DR, FIHBA-402a-DRLH, FIHBA-402a-DRHG

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996058018
Basic UDI-DI: 69509960FIHBA-402a-DRES
Reference: FIHBA-402a-DRHG
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Germany
Safety summary (SSCP/SSP): CEDR-FIHBA-402a-11.1-OG · Rev. 3.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 09.10.2026 02:10

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

CRP Quantitative Test Kit (Time-Resolved FIA)

FDWCR-402a-DR10, FDWCR-402a-DR10LH, FDWCR-402a-DR10HG, FDWCR-402a-DR, FDWCR-402a-DRLH, FDWCR-402a-DRHG

IVD Class BIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996049535
Basic UDI-DI: 69509960FDWCR-402a-DR4R
Reference: FDWCR-402a-DRHG
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 09.10.2026 02:10

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Quantitative Test Kit (Time-Resolved FIA)

FDTRO-402b-DR10, FDTRO-402b-DR10LH, FDTRO-402b-DR10HG, FDTRO-402b-DR, FDTRO-402b-DRLH, FDTRO-402b-DRHG

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996055918
Basic UDI-DI: 69509960FDTRO-402b-DRDH
Reference: FDTRO-402b-DRHG
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Safety summary (SSCP/SSP): CEDR-FDTRO-402b-11.1-OG · Rev. 4.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 09.10.2026 02:10

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

FDCAR-T402a-DR10, FDCAR-T402a-DR10LH, FDCAR-T402a-DR10HG, FDCAR-T402a-DR, FDCAR-T402a-DRLH, FDCAR-T402a-DRHG

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996047043
Basic UDI-DI: 69509960FDCAR-T402a-DRQ4
Reference: FDCAR-T402a-DRHG
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Safety summary (SSCP/SSP): CEDR-FDCAR-T402a-11-OG · Rev. 4.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 09.10.2026 02:10

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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

FAHCG-402a-DR10, FDHCG-402a-DR10LH, FDHCG-402a-DR10HG, FAHCG-402a-DR, FDHCG-402a-DRLH, FDHCG-402a-DRHG

IVD Class BIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996066884
Basic UDI-DI: 69509960FAHCG-402a-DRAR
Reference: FAHCG-402a-DRHG
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 09.10.2026 02:10

Manufacturer products Authorised representative products Authorised representative actors View details

D-CVCBZK01-AOGLC

CVCBZK01-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CVCBZK01-AOGLC
Basic UDI-DI: B-CVCBZK01-AOGLC
Reference: CVCBZK01-AOG4E
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.10.2026 01:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-CVCB801A-AOGQE

CVCB801A-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CVCB801A-AOGQE
Basic UDI-DI: B-CVCB801A-AOGQE
Reference: CVCB801A-AOG4E
EMDN: W0105070506
EMDN description: TROPICAL FEVER - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.10.2026 01:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-CVCB601A-AOGP8

CVCB601A-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CVCB601A-AOGP8
Basic UDI-DI: B-CVCB601A-AOGP8
Reference: CVCB601A-AOG4E
EMDN: W0105070506
EMDN description: TROPICAL FEVER - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.10.2026 01:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-CVAGZK01-AOGN5

CVAGZK01-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CVAGZK01-AOGN5
Basic UDI-DI: B-CVAGZK01-AOGN5
Reference: CVAGZK01-AOG4E
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.10.2026 01:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-CVAG01A-AOGSV

CVAG01A-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CVAG01A-AOGSV
Basic UDI-DI: B-CVAG01A-AOGSV
Reference: CVAG01A-AOG4E
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.10.2026 01:50

Manufacturer products Authorised representative products Authorised representative actors View details

D-CSTIZK01A-AOGJC

CSTIZK01A-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CSTIZK01A-AOGJC
Basic UDI-DI: B-CSTIZK01A-AOGJC
Reference: CSTIZK01A-AOG4E
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.10.2026 01:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-CSTIBZK01-AOGJ9

CSTIBZK01-AOG4E

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CSTIBZK01-AOGJ9
Basic UDI-DI: B-CSTIBZK01-AOGJ9
Reference: CSTIBZK01-AOG4E
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.10.2026 01:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-CSTIAZK01-AOGHJ

CSTIAZK01-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CSTIAZK01-AOGHJ
Basic UDI-DI: B-CSTIAZK01-AOGHJ
Reference: CSTIAZK01-AOG4E
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.10.2026 01:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-CSTI7B01A-AOGLG

CSTI7B01A-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CSTI7B01A-AOGLG
Basic UDI-DI: B-CSTI7B01A-AOGLG
Reference: CSTI7B01A-AOG4E
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.10.2026 01:47

Manufacturer products Authorised representative products Authorised representative actors View details

D-CSTI7A01A-AOGKV

CSTI7A01A-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CSTI7A01A-AOGKV
Basic UDI-DI: B-CSTI7A01A-AOGKV
Reference: CSTI7A01A-AOG4E
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.10.2026 01:47

Manufacturer products Authorised representative products Authorised representative actors View details

D-CSTI6ZK01A-AOGNS

CSTI6ZK01A-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CSTI6ZK01A-AOGNS
Basic UDI-DI: B-CSTI6ZK01A-AOGNS
Reference: CSTI6ZK01A-AOG4E
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.10.2026 01:47

Manufacturer products Authorised representative products Authorised representative actors View details