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Access AMH Advanced (Reagent Pack)

C62997

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: IMMUNOTECH SAS
Manufacturer SRN: FR-MF-000011121
UDI-DI: 15099590740481
Basic UDI-DI: 150995903AccAMHAdFB
Reference: C629997
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 11:50

Manufacturer products View details

Access AMH Reagent Pack

B13127

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: IMMUNOTECH SAS
Manufacturer SRN: FR-MF-000011121
UDI-DI: 15099590669263
Basic UDI-DI: 150995903AccAMHN5
Reference: B13127
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 11:49

Manufacturer products View details

Access Total βhCG (Reagent Pack)

C28645

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590744380
Basic UDI-DI: 150995901A9000TBhCGLA
Reference: C28645
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

Access Unconjugated Estriol (Reagent Pack)

C22255

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590702120
Basic UDI-DI: 150995901AccEstriol56
Reference: C22255
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

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: 06971390439869
Basic UDI-DI: 697139043040988
Reference: 010409101
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

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