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β-human Chorionic Gonadotropin (β-HCG) Test Kit(CLIA)

β-human Chorionic Gonadotropin (β-HCG) Test Kit(CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-CI-BHCGNC
Basic UDI-DI: B-CI-BHCGNC
Reference: CI-βHCG
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0012WCZ

Human Chorionic Gonadotrophin (HCG) Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0012WCZ
Basic UDI-DI: B-697994388Ir0012WCZ
Reference: Ir001
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

iGFBP-1 Rapid Test

iGFBP-1 Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840308440
Basic UDI-DI: B-69743840308440
Reference: 3010201
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

fFN Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840304794
Basic UDI-DI: B-69743840304794
Reference: 3010301
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy One Step Rapid Test

Pregnancy One Step Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840303254
Basic UDI-DI: B-69743840303254
Reference: 3010102
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:10

Manufacturer products Authorised representative products Authorised representative actors View details

β-Human Chorionic Gonadotropin (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-6-63AJ
Basic UDI-DI: B-6-63AJ
Reference: "REF: USIA00000087M, USIA00000088M"
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
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

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

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

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

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

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

b-HCG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDNOV03408
Basic UDI-DI: B-+ENTIDNOV03408
Reference: DNOV034
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

STANDARD™ i β-hCG

i-HCG-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724169
Basic UDI-DI: 88001117IPBA01IA15W4
Reference: 16BHC10D
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Total hCG

IVDR_67_TTN_DUB-C_C_KIT_ThCG

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414505152
Basic UDI-DI: 0405686901823VW
Reference: 10308984
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Placental Growth Factor (PlGF)

IVDR_67_LLB_DUB-C_C_REAG_Placental Growth Factor

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414290355
Basic UDI-DI: 0405686902128VC
Reference: 11200232
EMDN: W0102050211
EMDN description: PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Soluble fms-like Tyrosine Kinase-1 (sFlt-1)

IVDR_67_LLB_DUB-C_C_REAG_Soluble fms-like Tyrosine Kinase-1

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414015583
Basic UDI-DI: 0405686902122UY
Reference: 10997829
EMDN: W0102050212
EMDN description: SOLUBLE FMS-LIKE TYROSINE KINASE-1
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Unconjugated Estriol

IVDR_67_LLB_DUB-C_C_REAG_KIT_Unconjugated Estriol

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414971698
Basic UDI-DI: 0405686901473VR
Reference: 10381171
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 PAPP-A

IVDR_67_LLB_DUB-C_C_KIT_PAPP-A

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961835
Basic UDI-DI: 0405686901458VV
Reference: 10381213
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details