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847 device results listed.

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HOKAPI™ BETA-HCG

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439852
Basic UDI-DI: 697139043040988
Reference: 010409401
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP hCG PREGNANCY TEST

midstream 12test

IVD self-testing devicesIVDDOn the marketInstrumentKitSelf testingSingle use

Manufacturer: Qingdao AIBO Diagnostic Co., LTD
Manufacturer SRN: CN-MF-000041127
UDI-DI: 06970871280068
Basic UDI-DI: B-06970871280068
Reference: midstream 12test
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 30.06.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP hCG PREGNANCY TEST

midstream 1test

IVD self-testing devicesIVDDOn the marketInstrumentKitSelf testingSingle use

Manufacturer: Qingdao AIBO Diagnostic Co., LTD
Manufacturer SRN: CN-MF-000041127
UDI-DI: 06970871280051
Basic UDI-DI: B-06970871280051
Reference: midstream 1test
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 30.06.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

06970664751652

Anti-Müllerian Hormone Rapid Test Kit (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664751652
Basic UDI-DI: B-06970664751652
Reference: 25Tests/Kit
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Mullerian Hormone (AMH) Assay Kit (Chemiluminescent Immunoassay)

2×50 test/box Calibrator:0.5mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522649589
Basic UDI-DI: B-06970522649589
Reference: CL1402
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 04:48

Manufacturer products Authorised representative products Authorised representative actors View details

Progesterone (Prog) Assay Kit (Chemiluminescent Immunoassay)

2×50 test/box Calibrator:0.5mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522649558
Basic UDI-DI: B-06970522649558
Reference: CL1602
EMDN: W0102050204
EMDN description: ESTRONE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 04:48

Manufacturer products Authorised representative products Authorised representative actors View details

Inhibin-B(INHB) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522649008
Basic UDI-DI: B-06970522649008
Reference: CL2201
EMDN: W0102050214
EMDN description: INHIBIN A/B (PRENATAL SCREENING)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 04:47

Manufacturer products Authorised representative products Authorised representative actors View details

2×50 test/box Calibrator:0.5mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522641651
Basic UDI-DI: B-06970522641651
Reference: CL1703
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 04:45

Manufacturer products Authorised representative products Authorised representative actors View details

Total Beta Human Chorionic Gonadotropin (Total β-HCG) eCLIA

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

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341685959
Basic UDI-DI: 69703416803205006J7
Reference: 697041
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 01:58

Manufacturer products Authorised representative products Authorised representative actors View details

Total Beta Human Chorionic Gonadotropin (Total β-HCG) eCLIA

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

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341685942
Basic UDI-DI: 69703416803205006J7
Reference: 697039
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 01:58

Manufacturer products Authorised representative products Authorised representative actors View details

Total Beta Human Chorionic Gonadotropin (Total β-HCG) eCLIA

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

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341680954
Basic UDI-DI: 69703416803205006J7
Reference: 697042
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 01:54

Manufacturer products Authorised representative products Authorised representative actors View details

06926802605363

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802605363
Basic UDI-DI: 69268026MD761F0000000013C
Reference: MCL05802E
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: -
Authorised representative: R Sight B.V.
Last updated: 29.06.2026 22:59

Manufacturer products Authorised representative products Authorised representative actors View details

06926802605370

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802605370
Basic UDI-DI: 69268026MD761F0000000013C
Reference: MCL05803E
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: -
Authorised representative: R Sight B.V.
Last updated: 29.06.2026 22:59

Manufacturer products Authorised representative products Authorised representative actors View details

Total β Human Chorionic Gonadotrophin (CLIA)

IVD Class BNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053157896
Basic UDI-DI: 69449040004H-HCG-II****HG
Reference: 105-064646-00
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:10

Manufacturer products Authorised representative products Authorised representative actors View details

06956013950068

Card type: 25 pieces/box; Pen type: 1 piece/box, 2 pieces/box, 5 pieces/box.

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: AVE Science & Technology Co., Ltd.
Manufacturer SRN: CN-MF-000031214
UDI-DI: 06956013950068
Basic UDI-DI: B-06956013950068
Reference: --
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 21:35

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy-associated plasma protein-A Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792701366
Basic UDI-DI: B-06955792701366
Reference: S2093E-24
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy-associated plasma protein-A Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792701359
Basic UDI-DI: B-06955792701359
Reference: S2093E-48
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL PAPP-A (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798920
Basic UDI-DI: B-06954414798920
Reference: /
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:34

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL free β-HCG (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798661
Basic UDI-DI: B-06954414798661
Reference: /
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:34

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL β-HCG (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798128
Basic UDI-DI: B-06954414798128
Reference: /
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:32

Manufacturer products Authorised representative products Authorised representative actors View details