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IMMULITE 2000 Free Beta HCG

IVDR_67_LLB_DUB-C_C_KIT_Free Beta HCG

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961446
Basic UDI-DI: 0405686901450VD
Reference: 10381175
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
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

N/A

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-Z033204R
Basic UDI-DI: B-Z033204R
Reference: Z03320
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 14:12

Manufacturer products View details

Estrone-3-Glucuronide Test Kit (FIA)

VID53

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID5334
Basic UDI-DI: B-VID5334
Reference: VID53-05-011
EMDN: W0102050204
EMDN description: ESTRONE
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Beta Human Chorionic Gonadotropin Test Kit (FIA)

VID19

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID1934
Basic UDI-DI: B-VID1934
Reference: VID19-05-011
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:21

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy-Associated Plasma Protein A Test Kit (FIA)

VID143

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID143EX
Basic UDI-DI: B-VID143EX
Reference: VID143-05-011
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Estriol Test Kit (FIA)

VID142

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID142EV
Basic UDI-DI: B-VID142EV
Reference: VID142-05-011
EMDN: W0102050202
EMDN description: ESTRIOL
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Free Beta Human Chorionic Gonadotrophin Test Kit (FIA)

VID141

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID141ET
Basic UDI-DI: B-VID141ET
Reference: VID141-05-011
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-3548

PLGF & sFLT-1 Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-3548
Basic UDI-DI: B-TD-HNKX-CED-3548
Reference: /
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-313Y

Human Chorionic Gonadotropin Beta-subunit Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-313Y
Basic UDI-DI: B-TD-HNKX-CED-313Y
Reference: /
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-103Q

Anti-Mullerian Hormone Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-103Q
Basic UDI-DI: B-TD-HNKX-CED-103Q
Reference: /
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details

Total β-HCG Total β-Human Chorionic Gonadotropin (CLIA)

Total β-HCG Total β-Human Chorionic Gonadotropin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-TB-HCG706-AEN4
Basic UDI-DI: B-TB-HCG706-AEN4
Reference: TB-HCG706-AE10Y, TB-HCG706-AE10N, TB-HCG706-AE20Y, TB-HCG706-AE20N
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i β-hCG

-

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724176
Basic UDI-DI: 88001117IPBA01IA15W4
Reference: 16BHC10F
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022033ED
Basic UDI-DI: B-SAC2022033ED
Reference: SAC2022033
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022032EB
Basic UDI-DI: B-SAC2022032EB
Reference: SAC2022032
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

10 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022031E9
Basic UDI-DI: B-SAC2022031E9
Reference: SAC2022031
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

ADVIA Centaur Total hCG

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414505176
Basic UDI-DI: 0405686901823VW
Reference: 10308985
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 14.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-PREGNANCYTESTBQ

Pregnancy Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesReagentSelf testingSingle use

Manufacturer: Sanavita Pharmaceuticals GmbH
Manufacturer SRN: DE-MF-000005463
UDI-DI: D-PREGNANCYTESTBQ
Basic UDI-DI: B-PREGNANCYTESTBQ
Reference: PREGNANCYTEST
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 17:12

Manufacturer products View details

48 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-MFG030063QW
Basic UDI-DI: B-MFG030063QW
Reference: MFG030063
EMDN: W0102050212
EMDN description: SOLUBLE FMS-LIKE TYROSINE KINASE-1
First on market country: Denmark
Authorised representative: -
Last updated: 14.07.2026 05:06

Manufacturer products View details

INNODX T-β-HCG CMIA

INNODX T-β-HCG CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-T-B-HCG-01100C2Y
Basic UDI-DI: B-KR-T-B-HCG-01100C2Y
Reference: KR-T-β-HCG-01100C
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX F-β-HCG CMIA

INNODX F-β-HCG CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-F-B-HCG-01100CG3
Basic UDI-DI: B-KR-F-B-HCG-01100CG3
Reference: KR-F-β-HCG-01100C
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details