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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

12.10.2026 19:30

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Active filter:Manufacturer SRN:CN-MF-000017965

727 device results listed.

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D-CGIZK01-AOG6N

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CGIZK01-AOG6N
Basic UDI-DI: B-CGIZK01-AOG6N
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 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

CGIBAC-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CGIBAC-AOGYU
Basic UDI-DI: B-CGIBAC-AOGYU
Reference: CGIBAC-AOG4E
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.10.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-CGI601A-AOG9J

CGI601A-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CGI601A-AOG9J
Basic UDI-DI: B-CGI601A-AOG9J
Reference: CGI601A-AOG4E
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.10.2026 00:21

Manufacturer products Authorised representative products Authorised representative actors View details

D-CGCT01A-AOGNF

CGCT01A-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CGCT01A-AOGNF
Basic UDI-DI: B-CGCT01A-AOGNF
Reference: CGCT01A-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 00:21

Manufacturer products Authorised representative products Authorised representative actors View details

D-CGBSZK01A-AOGTZ

CGBSZK01A-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CGBSZK01A-AOGTZ
Basic UDI-DI: B-CGBSZK01A-AOGTZ
Reference: CGBSZK01A-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 00:21

Manufacturer products Authorised representative products Authorised representative actors View details

D-CGBS01A-AOGM5

CGBS01A-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CGBS01A-AOGM5
Basic UDI-DI: B-CGBS01A-AOGM5
Reference: CGBS01A-AOG4E
EMDN: W0105011102
EMDN description: STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.10.2026 00:21

Manufacturer products Authorised representative products Authorised representative actors View details

D-CFFCR01A-AOGT7

CFFCR01A-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CFFCR01A-AOGT7
Basic UDI-DI: B-CFFCR01A-AOGT7
Reference: CFFCR01A-AOG4E
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.10.2026 00:19

Manufacturer products Authorised representative products Authorised representative actors View details

D-CDGVZK01-AOGLW

CDGVZK01-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CDGVZK01-AOGLW
Basic UDI-DI: B-CDGVZK01-AOGLW
Reference: CDGVZK01-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 00:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-CDGV01A-AOGPS

CDGV01A-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CDGV01A-AOGPS
Basic UDI-DI: B-CDGV01A-AOGPS
Reference: CDGV01A-AOG4E
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.10.2026 00:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-CCNSZK01-AOGQ5

CCNSZK01-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CCNSZK01-AOGQ5
Basic UDI-DI: B-CCNSZK01-AOGQ5
Reference: CCNSZK01-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 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-CCNS801A-AOGU7

CCNS801A-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CCNS801A-AOGU7
Basic UDI-DI: B-CCNS801A-AOGU7
Reference: CCNS801A-AOG4E
EMDN: W0105070505
EMDN description: MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.10.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-CCDIFZK01-AOGK2

CCDIFZK01-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CCDIFZK01-AOGK2
Basic UDI-DI: B-CCDIFZK01-AOGK2
Reference: CCDIFZK01-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 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-CCDIF01A-AOGKN

CCDIF01A-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CCDIF01A-AOGKN
Basic UDI-DI: B-CCDIF01A-AOGKN
Reference: CCDIF01A-AOG4E
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.10.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-CAMRZK01-AOGLK

CAMRZK01-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CAMRZK01-AOGLK
Basic UDI-DI: B-CAMRZK01-AOGLK
Reference: CAMRZK01-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 00:11

Manufacturer products Authorised representative products Authorised representative actors View details

D-CAMR801A-AOGQM

CAMR801A-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-CAMR801A-AOGQM
Basic UDI-DI: B-CAMR801A-AOGQM
Reference: CAMR801A-AOG4E
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.10.2026 00:10

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960CSTI401A97

CSTI401A-AOG4E

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960CSTI401A97
Basic UDI-DI: B-69509960CSTI401A97
Reference: CSTI401A-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: 06.10.2026 21:10

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Influenza A & B Antigen Test

GCFLU(A/B)-502a-DRH1,GCFLU(A/B)-502a-DRH2,GCFLU(A/B)-502a-DRH5,GCFLU(A/B)-502a-DRH7,GCFLU(A/B)-502a-DRH20

IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002615
Basic UDI-DI: 69509960GCFLUAB502aDRHGQ
Reference: GCFLU(A/B)-502a-DRH2
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Safety summary (SSCP/SSP): CEDR-SSP-OG005 · Rev. 1.5
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.09.2026 13:30

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

Rapid Influenza A & B Antigen Test

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IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002639
Basic UDI-DI: 69509960GCFLUAB502aDRHGQ
Reference: GCFLU(A/B)-502a-DRH7
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: -
Safety summary (SSCP/SSP): CEDR-SSP-OG005 · Rev. 1.5
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 09:09

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

Easy @ Home® Pregnancy Test

EZW1-S-20

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-EZW1-S-20CD
Basic UDI-DI: B-EZW1-S-20CD
Reference: EZW1-S-20
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 02:27

Manufacturer products Authorised representative products Authorised representative actors View details

URcheck™ NeoChem Analyzer

AC-H800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996046930
Basic UDI-DI: 69509960AC-H800DE
Reference: AC-H800
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 16:20

Manufacturer products Authorised representative products Authorised representative actors View details