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40 device results listed.

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Diagnostic Kit for Pan/ P.falciparum Antigen (Colloidal Gold)

MA-Pan/Pf strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757991703QP
Basic UDI-DI: B-693757991703QP
Reference: MA-Pan/Pf 50170301 MA-Pan/Pf 25170302
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for P.falciparum Antigen （Colloidal Gold)

MA-Pf strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757991702QM
Basic UDI-DI: B-693757991702QM
Reference: MA-Pf 50170101 MA-Pf 25170102
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:49

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Diagnostic Kit for P.falciparum /P.vivax Antigen(Colloidal Gold)

MA-Pf/Pv strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757991701QK
Basic UDI-DI: B-693757991701QK
Reference: MA-Pf/Pv 50170201 MA-Pf/Pv 25170202
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Helicobacter pylori antigen (Colloidal Gold)

HP-Ag strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757991602QG
Basic UDI-DI: B-693757991602QG
Reference: HP-Ag501601 HP-Ag251602
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antibody (HP) Test

HP strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757991601QE
Basic UDI-DI: B-693757991601QE
Reference: HP strip cassette
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Reagent Strips

100 strips/bottle

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990URS25
Basic UDI-DI: B-693757990URS25
Reference: Urinalysis reagent strip
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

Typhoid IgG/IgM test cassette

Typhoid-IgG/IgM cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990620QB
Basic UDI-DI: B-693757990620QB
Reference: Typhoid-IgG/IgM 252002
EMDN: W0105011002
EMDN description: SALMONELLA ANTIBODY ASSAYS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/Flu A+B/RSV Antigen Rapid Test

SARS-CoV-2/Flu A+B/RSV Antigen cassette

IVD generalIVDDNo longer on the marketKitProfessional testingReagentSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990638QW
Basic UDI-DI: B-693757990638QW
Reference: SARS-CoV-2/Flu A+B/RSV Antigen cassette
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic kit for Antibody to Treponema Pallidum (Colloidal Gold)

TP strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990609QP
Basic UDI-DI: B-693757990609QP
Reference: TP500901 TP250902
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic kit for anti-HAV IgM( Colloidal Gold)

HAV-IgM strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990612QC
Basic UDI-DI: B-693757990612QC
Reference: HAV-IgM 501201 HAV-IgM 251202
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate Specific Antigen (PSA) Test

strip cassette

IVD Annex II List BIVDDOn the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990607QK
Basic UDI-DI: B-693757990607QK
Reference: strip cassette
EMDN: W0102030122
EMDN description: EARLY PROSTATE CANCER ANTIGEN - 2
First on market country: Northern Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood (FOB)Test

FOB strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990606QH
Basic UDI-DI: B-693757990606QH
Reference: FOB strip cassette
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Ovulation (LH) Test for Self Testing

strip cassette midstream

IVD self-testing devicesIVDDOn the marketProfessional testingSelf testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990602Q9
Basic UDI-DI: B-693757990602Q9
Reference: LH strip cassette midstream
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Fast Diagnostic Screening Test for Sperm Concentration

cassette

IVD self-testing devicesIVDDOn the marketSelf testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990302PS
Basic UDI-DI: B-693757990302PS
Reference: JZMD cassette
EMDN: W0102109013
EMDN description: SPERM ANTIBODIES
First on market country: Northern Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Follicle Stimulating Hormone (FSH) Test

strip cassette midstream

IVD self-testing devicesIVDDOn the marketProfessional testingSelf testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990301PQ
Basic UDI-DI: B-693757990301PQ
Reference: FSH strip cassette midstream
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Test de grossesse

midstream

IVD self-testing devicesIVDDOn the marketSelf testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990102PG
Basic UDI-DI: B-693757990102PG
Reference: HCG midstream
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy Test for Self Testing

strip cassette

IVD self-testing devicesIVDDOn the marketProfessional testingSelf testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990101PE
Basic UDI-DI: B-693757990101PE
Reference: HCG strip cassette
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Test Ciążowy hCG płytkowy HELTES

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: 06937579912042
Basic UDI-DI: B-06937579912042
Reference: HCG-C
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Poland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.06.2026 23:35

Manufacturer products Authorised representative products Authorised representative actors View details

SEMA PROTECT

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: 06937579911144
Basic UDI-DI: B-06937579911144
Reference: LHS-5
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Poland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.06.2026 23:35

Manufacturer products Authorised representative products Authorised representative actors View details

SEMA PROTECT

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: 06937579911137
Basic UDI-DI: B-06937579911137
Reference: HCG-C
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Poland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.06.2026 23:35

Manufacturer products Authorised representative products Authorised representative actors View details