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06939663978484

IVD generalNot specifiedOn the market

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663978484
Basic UDI-DI: B-06939663978484
Reference: ISIRA-9445
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.06.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Monitoring system

IVD Annex II List BNot specifiedOn the market

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663988001
Basic UDI-DI: B-06939663988001
Reference: BG-707
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

Digital Fertility Testing System

IVD self-testing devicesNot specifiedOn the market

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663987103
Basic UDI-DI: B-06939663987103
Reference: Digital Fertility Tracker and LH One Step Ovulation Test
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663985307
Basic UDI-DI: B-06939663985307
Reference: ISTA-8112
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

URINALYSIS REAGENT STRIPS

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663985109
Basic UDI-DI: B-06939663985109
Reference: URS-022
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

URINALYSIS REAGENT STRIPS

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663985086
Basic UDI-DI: B-06939663985086
Reference: URS-110
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

URINALYSIS REAGENT STRIPS

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663985024
Basic UDI-DI: B-06939663985024
Reference: URS-140
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

LH One Step Ovulation Test

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663984065
Basic UDI-DI: B-06939663984065
Reference: LH-101/LH-102/LH-103
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

LH One Step Ovulation Test

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663984010
Basic UDI-DI: B-06939663984010
Reference: Strip,Cassette,Midstream
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

hCG One Step Pregnancy Test

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663982061
Basic UDI-DI: B-06939663982061
Reference: Strip,Cassette,Midstream
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

Lipid Panel Monitoring System

IVD generalNot specifiedOn the market

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663979016
Basic UDI-DI: B-06939663979016
Reference: BF-101
EMDN: W01010228
EMDN description: TOTAL LIPIDS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

06939663978675

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663978675
Basic UDI-DI: B-06939663978675
Reference: ISIRA-9445
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

06939663978576

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663978576
Basic UDI-DI: B-06939663978576
Reference: ISIRAH-9655
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663978415
Basic UDI-DI: B-06939663978415
Reference: ISIR-9334
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663978323
Basic UDI-DI: B-06939663978323
Reference: COIF-522
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

Typhoid IgG/IgM Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663977968
Basic UDI-DI: B-06939663977968
Reference: Cassette
EMDN: W0105011002
EMDN description: SALMONELLA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f ＆P.v Rapid Test (Whole Blood)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663977951
Basic UDI-DI: B-06939663977951
Reference: Cassette
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f ＆Pan Rapid Test (whole blood)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663977944
Basic UDI-DI: B-06939663977944
Reference: Cassette
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Plasmodium Falciparum Rapid Test (whole blood)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663977937
Basic UDI-DI: B-06939663977937
Reference: Cassette
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Antibody Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663977920
Basic UDI-DI: B-06939663977920
Reference: Cassette
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:04

Manufacturer products Authorised representative products Authorised representative actors View details