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827 device results listed.

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Atellica IM Total hCG (ThCG)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600031
Basic UDI-DI: 0405686901823VW
Reference: 10995690
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Total β-HCG STAT

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984064185
Basic UDI-DI: 69703416803205099K8
Reference: 0320509302
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 09.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Total β-HCG STAT

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984064192
Basic UDI-DI: 69703416803205099K8
Reference: 0320509303
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 09.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Total β-HCG STAT

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984064208
Basic UDI-DI: 69703416803205099K8
Reference: 0320509304
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 09.07.2026 22:51

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IMMULITE 2000 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: 00630414997162
Basic UDI-DI: 0405686901473VR
Reference: 10381192
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 09.07.2026 22:44

Manufacturer products Authorised representative products Authorised representative actors View details

08800026300106

Exdia β-hCG

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Precision Biosensor Inc.
Manufacturer SRN: KR-MF-000034861
UDI-DI: 08800026300106
Basic UDI-DI: B-08800026300106
Reference: PR-FC10
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 09.07.2026 20:52

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RapidFor™ AMH Rapid Test Kit (FIA)

VMPO42

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250803
Basic UDI-DI: B-08683548250803
Reference: VMPO42
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:10

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RapidFor™ β-HCG (FIA)

VMPO15EP

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250261
Basic UDI-DI: B-08683548250261
Reference: VMPO15
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:09

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EUROSPITAL - TEST DI GRAVIDANZA IN AUTODIAGNOSI

EUROSPITAL - TEST DI GRAVIDANZA

IVD self-testing devicesIVDDOn the marketReagentSelf testingSingle use

Manufacturer: Logiter One Srl
Manufacturer SRN: IT-MF-000037076
UDI-DI: 08050593875211
Basic UDI-DI: B-08050593875211
Reference: TGLOG-14
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 19:10

Manufacturer products View details

TEST DI GRAVIDANZA - PROTEC 1PZ

TEST DI GRAVIDANZA PROTEC 1 PZ

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Logiter One Srl
Manufacturer SRN: IT-MF-000037076
UDI-DI: 08050593875204
Basic UDI-DI: B-08050593875204
Reference: TESTG001BH
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 19:10

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TEST DI GRAVIDANZA

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Logiter One Srl
Manufacturer SRN: IT-MF-000037076
UDI-DI: 08050593875105
Basic UDI-DI: B-08050593875105
Reference: 5017
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 19:10

Manufacturer products View details

FREETOUCH - 2 PZ

TGLOG

IVD self-testing devicesIVDDOn the marketReagentSelf testingSingle use

Manufacturer: Logiter One Srl
Manufacturer SRN: IT-MF-000037076
UDI-DI: 08050593875013
Basic UDI-DI: B-08050593875013
Reference: 5001
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 19:10

Manufacturer products View details

08034049110149

b-HCG ELISA

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Dia.Metra Srl
Manufacturer SRN: IT-MF-000027206
UDI-DI: 08034049110149
Basic UDI-DI: B-08034049110149
Reference: DKO014
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 18:01

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Sharay Anti-Trophoblast Cell Membrane (CLIA)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06980070460055
Basic UDI-DI: B-06980070460055
Reference: 14000777
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 07.07.2026 02:53

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-hCG IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06980070460048
Basic UDI-DI: B-06980070460048
Reference: 14000778
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 07.07.2026 02:53

Manufacturer products Authorised representative products Authorised representative actors View details

06979878281115

Anti-Muellerian Hormone Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Huzhou Jierunxin Biotechnology Co., LTD
Manufacturer SRN: CN-MF-000047637
UDI-DI: 06979878281115
Basic UDI-DI: B-06979878281115
Reference: 1001047
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 02:50

Manufacturer products Authorised representative products Authorised representative actors View details

06979878281122

Beta-subunit of Human Chorionic Gonadotropin Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Huzhou Jierunxin Biotechnology Co., LTD
Manufacturer SRN: CN-MF-000047637
UDI-DI: 06979878281122
Basic UDI-DI: B-06979878281122
Reference: 1001048
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 02:50

Manufacturer products Authorised representative products Authorised representative actors View details

Beta Human Chorionic Gonadotropin Test Kit

G1404CC

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06979469761552
Basic UDI-DI: B-06979469761552
Reference: G1404CC
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 02:44

Manufacturer products Authorised representative products Authorised representative actors View details

Beta Human Chorionic Gonadotropin Test Kit

G1403CC

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06979469761569
Basic UDI-DI: B-06979469761569
Reference: G1403CC
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 02:44

Manufacturer products Authorised representative products Authorised representative actors View details

Beta Human Chorionic Gonadotropin Test Kit

G1402CC

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06979469761545
Basic UDI-DI: B-06979469761545
Reference: G1402CC
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 02:44

Manufacturer products Authorised representative products Authorised representative actors View details