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Luteinizing Hormone Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 10850076346130
Basic UDI-DI: B-10850076346130
Reference: CALH-301a
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 04:36

Manufacturer products Authorised representative products Authorised representative actors View details

RAMP Total b-hCG

RAMP Total b-hCG (C1117)

IVD generalIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Response Biomedical Corp.
Manufacturer SRN: CA-MF-000034747
UDI-DI: 10627966005275
Basic UDI-DI: B-10627966005275
Reference: C1117
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 02:21

Manufacturer products Authorised representative products Authorised representative actors View details

PROG STAT (eCLIA)

IVD Class BNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063799
Basic UDI-DI: 69703416803205098K6
Reference: 0320510603
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

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: 00630414600024
Basic UDI-DI: 0405686901823VW
Reference: 10995689
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

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

FREND Testosterone

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540375
Basic UDI-DI: B-08809317540375
Reference: FRTEAP 020
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

FREND Testosterone

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540153
Basic UDI-DI: B-08809317540153
Reference: FRTE 020
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Cyprus
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

SHBG (eCLIA)

IVD Class BNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063706
Basic UDI-DI: 69703416803205096K2
Reference: 0320509002
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 09.07.2026 06:34

Manufacturer products Authorised representative products Authorised representative actors View details

SHBG (eCLIA)

IVD Class BNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063713
Basic UDI-DI: 69703416803205096K2
Reference: 0320509003
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 09.07.2026 06:34

Manufacturer products Authorised representative products Authorised representative actors View details

SHBG (eCLIA)

IVD Class BNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063720
Basic UDI-DI: 69703416803205096K2
Reference: 0320509004
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 09.07.2026 06:34

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™ TES Rapid Test Kit (FIA)

VMPO41

IVD generalIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595039366
Basic UDI-DI: B-08684595039366
Reference: VMPO41FC
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:19

Manufacturer products View details

RapidFor™ TES Rapid Test Kit (FIA)

VMPO41

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595038796
Basic UDI-DI: B-08684595038796
Reference: VMPO41EP
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:17

Manufacturer products View details

RapidFor™ PROG Rapid Test Kit (FIA)

VMPO36

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595036686
Basic UDI-DI: B-08684595036686
Reference: VMPO36EP
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:16

Manufacturer products View details

RapidFor™Sex Hormone Binding Globunin Test Kit (FIA)

VMPO54

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250926
Basic UDI-DI: B-08683548250926
Reference: VMPO54
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:10

Manufacturer products View details

RapidFor™Estradiol (E2) Rapid Test Kit (FIA)

VMPO43

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250810
Basic UDI-DI: B-08683548250810
Reference: VMPO43
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:10

Manufacturer products View details