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19.09.2026 16:17

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229 device results listed.

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AMAZON BASIC CARE OVULATION TESTS

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 05400606954236
Basic UDI-DI: B-05400606954236
Reference: 860045
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: France
Authorised representative: -
Last updated: 02.08.2026 19:39

Manufacturer products View details

04560189211667

AIA-PACK LHII SAMPLE DILUTING SOLUTION

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189211667
Basic UDI-DI: B-04560189211667
Reference: 0020596
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

04560189211650

ST AIA-PACK LHII CALIBRATOR SET

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189211650
Basic UDI-DI: B-04560189211650
Reference: 0025396
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

++B261CANLH4040JK

96 Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Diagnostics Biochem Canada Inc.
Manufacturer SRN: CA-MF-000032449
UDI-DI: ++B261CANLH4040JK
Basic UDI-DI: B-++B261CANLH4040JK
Reference: CAN-LH-4040
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 01.08.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details

Luteinizing Hormone test (Up-converting Phosphor Technology)

Please see the IFU

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700410051
Basic UDI-DI: 6970297531057AN
Reference: HGUPT33
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Luteinizing Hormone test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403190
Basic UDI-DI: 697029753299M9
Reference: HGCL16
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

LH CLIA Microparticles

AutoLumo Analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359543088
Basic UDI-DI: 697015090000026H2
Reference: CMF0105
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

Luteinizing Hormone (CLIA)

105-004223-00、105-004250-00、105-004292-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053158152
Basic UDI-DI: 69449040004H-LH********FV
Reference: 105-064651-00
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:36

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-LH

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912711797
Basic UDI-DI: 692591270011GN
Reference: C86010-L
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

VIDAS® LH

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064921
Basic UDI-DI: 357302BUDI000609TS
Reference: 30406
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

Manufacturer products View details

LH IRMA KIT

Immunoassay IM1381, IM3302

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590214401
Basic UDI-DI: 150995905LHIRMAHQ
Reference: IM1381
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

Manufacturer products View details

Luteinizing Hormone (LH) Diagnostic Kit ( Immunochromatographic Assay)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762742
Basic UDI-DI: 697134876015B2742YC
Reference: MF-015-20
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Luteinizing Hormone (LH) Diagnostic Kit ( Immunochromatographic Assay)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348764579
Basic UDI-DI: 697134876015B2742YC
Reference: MF-015-25
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Luteinizing Hormone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852791
Basic UDI-DI: B-06933289852791
Reference: WA66P0004
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Luteinizing Hormone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852784
Basic UDI-DI: B-06933289852784
Reference: WA66P0003
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Luteinizing Hormone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852777
Basic UDI-DI: B-06933289852777
Reference: WA66P0002
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Luteinizing Hormone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852760
Basic UDI-DI: B-06933289852760
Reference: WA66P0001
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

Luteinizing Hormone (LH) Diagnostic Kit ( Immunochromatographic Assay)

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762124
Basic UDI-DI: B-06971348762124
Reference: MF-15-25
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:52

Manufacturer products Authorised representative products Authorised representative actors View details

Luteinizing Hormone (LH) Diagnostic Kit ( Immunochromatographic Assay)

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760168
Basic UDI-DI: B-06971348760168
Reference: MF-15-20
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-R135142B

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R135142B
Basic UDI-DI: B-R135142B
Reference: R13514
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:59

Manufacturer products Authorised representative products Authorised representative actors View details