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609 device results listed.

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Healgen-800 Urine Analyzer

Healgen 800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996004039
Basic UDI-DI: 69509960healgen8008M
Reference: Healgen 800
EMDN: W02010701
EMDN description: URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer

Healgen 501

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996004022
Basic UDI-DI: 69509960healgen50188
Reference: Healgen 501
EMDN: W02010701
EMDN description: URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer

Healgen 500

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996004015
Basic UDI-DI: 69509960healgen50086
Reference: Healgen 500
EMDN: W02010701
EMDN description: URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

Multiplex Fluorescent Analyzer

OG-G260

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: 06950996003971
Basic UDI-DI: 69509960OG-G260MV
Reference: OG-G260
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: 28.06.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)

GCFCRA-T525a-DR

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002844
Basic UDI-DI: 69509960GCFCRA-T525aDR65
Reference: GCFCRA-T525a-DR
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

Hand-Held Immunofluorescence Analyzer

OG-G300

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: 06950996002752
Basic UDI-DI: 69509960OG-G300MG
Reference: OG-G300
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: 28.06.2026 09:32

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: 06950996002745
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: 28.06.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

Mini Immunofluorescence Analyzer

OG-H100

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: 06950996002738
Basic UDI-DI: 69509960OG-H100MD
Reference: OG-H100
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: 28.06.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

Digital Pregnancy Test

GAHCG-D103a-2T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002714
Basic UDI-DI: B-06950996002714
Reference: GAHCG-D103a-2T
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

Digital Pregnancy Test

GAHCG-D103a-1T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002707
Basic UDI-DI: B-06950996002707
Reference: GAHCG-D103a-1T
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

HCG Pregnancy Rapid Test

GAHCG-103a-5T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002691
Basic UDI-DI: B-06950996002691
Reference: GAHCG-103a-5T
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

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: 06950996002684
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: 28.06.2026 09:31

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 marketKitReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002646
Basic UDI-DI: 69509960GCFLUAB502aDRHGQ
Reference: GCFLU(A/B)-502a-DRH20
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:31

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 marketKitReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002622
Basic UDI-DI: 69509960GCFLUAB502aDRHGQ
Reference: GCFLU(A/B)-502a-DRH5
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:31

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 marketKitReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002608
Basic UDI-DI: 69509960GCFLUAB502aDRHGQ
Reference: GCFLU(A/B)-502a-DRH1
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Rapid Test Cassette (Feces)

GCROA-602a

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002462
Basic UDI-DI: B-06950996002462
Reference: GCROA-602a
EMDN: W0105040606
EMDN description: ROTAVIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood Rapid Test Cassette (Feces)

GEFOB-602b

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002448
Basic UDI-DI: B-06950996002448
Reference: GEFOB-602b
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Antigen Rapid Test Cassette (Swab)

GCRSV-502a

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002431
Basic UDI-DI: B-06950996002431
Reference: GCRSV-502a
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A & B Ag Rapid Test Cassette (Swab)

GCFLU(A/B)-502Ca

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002394
Basic UDI-DI: B-06950996002394
Reference: GCFLU(A/B)-502Ca
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A & B Ag Rapid Test Cassette (Swab)

GCFLU(A/B)-502a

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002387
Basic UDI-DI: B-06950996002387
Reference: GCFLU(A/B)-502a
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details