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D-6-58AR

Luteinizing Hormone (LH) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-58AR
Basic UDI-DI: B-6-58AR
Reference: "REF: USIA00000099M, USIA00000100M"
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:13

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-125FG

Inhibin B Assay Kit(Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-125FG
Basic UDI-DI: B-6-125FG
Reference: "REF: USIA00000219M, USIA00000220M"
EMDN: W0102050214
EMDN description: INHIBIN A/B (PRENATAL SCREENING)
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-102F4

Pregnancy-associated Plasma Protein A (PAPP-A) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-102F4
Basic UDI-DI: B-6-102F4
Reference: "REF: USIA00000105M., USIA00000106M "
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-101F2

free-β-Human Chorionic Gonadotropin (free-β-HCG) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-101F2
Basic UDI-DI: B-6-101F2
Reference: "REF: USIA00000103M, USIA00000104M"
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-100EY

Unconjugated Estriol (uE3) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-100EY
Basic UDI-DI: B-6-100EY
Reference: "REF: USIA00000101M, USIA00000102M"
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® LH

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771200134
Basic UDI-DI: B-08056771200134
Reference: 312201
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 22:32

Manufacturer products View details

PdG (Pregnanediol-3-Glucuronide) Rapid Test (Urine)

WPdG-4011

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anhui Formaster Biosci Co., Ltd.
Manufacturer SRN: CN-MF-000002305
UDI-DI: 06974785750617
Basic UDI-DI: B-06974785750617
Reference: WPdG-4011
EMDN: W0102050199
EMDN description: FERTILITY FUNCTION HORMONES - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

uE3 CLIA Microparticles

refer to IFU

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150908997
Basic UDI-DI: B-06970150908997
Reference: CMN0402
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

HCG Pregnancy Test (Urine/Serum/Plasma) (ColloidalGold)

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062771524
Basic UDI-DI: B-06952062771524
Reference: HCG USP
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

uE3 CLIA Microparticals

refer to IFU

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359505871
Basic UDI-DI: B-06942359505871
Reference: CMN0401
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 18:52

Manufacturer products Authorised representative products Authorised representative actors View details

+ENTIDSNOV270_

Androstenedione Saliva