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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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405 device results listed.

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STANDARD™ i LH

-

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724152
Basic UDI-DI: 88001117IPBA01IA33W6
Reference: 16LH10Q
EMDN: W0102160304
EMDN description: LH - RT & POC
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

DAVID, Family Care Med+, Z1 Pharma

20 mIU/mL, 25 mIU/mL, 35 mIU/mL, ≤1 mIU/mL

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: Equinox Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018901
UDI-DI: D-RH-LHZA
Basic UDI-DI: B-RH-LHZA
Reference: LH-MS1, LH-MS2, LH-LS, RH-sLH
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 05:27

Manufacturer products Authorised representative products Authorised representative actors View details

LH Test Kit FIA

LH Test Kit FIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-LH-D06aPR
Basic UDI-DI: B-LH-D06aPR
Reference: LH-D06a
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

LH Detection Kit (Immunofluorescence Chromatography)

LH Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD174XT
Basic UDI-DI: B-GKPD174XT
Reference: GKPD174
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103b-7T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GALH-103b-7TG9
Basic UDI-DI: B-GALH-103b-7TG9
Reference: GALH-103b-7T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103b-5T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GALH-103b-5THGNX
Basic UDI-DI: B-GALH-103b-5THGNX
Reference: GALH-103b-5T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103b-5T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GALH-103b-5TG3
Basic UDI-DI: B-GALH-103b-5TG3
Reference: GALH-103b-5T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103b-2T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GALH-103b-2THGNA
Basic UDI-DI: B-GALH-103b-2THGNA
Reference: GALH-103b-2T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103b-2T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GALH-103b-2TFS
Basic UDI-DI: B-GALH-103b-2TFS
Reference: GALH-103b-2T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103b-25T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GALH-103b-25TJ3
Basic UDI-DI: B-GALH-103b-25TJ3
Reference: GALH-103b-25T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103b-25T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GALH-103b-25THGTR
Basic UDI-DI: B-GALH-103b-25THGTR
Reference: GALH-103b-25T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103b-1T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GALH-103b-1THGN3
Basic UDI-DI: B-GALH-103b-1THGN3
Reference: GALH-103b-1T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103b-1T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GALH-103b-1TFP
Basic UDI-DI: B-GALH-103b-1TFP
Reference: GALH-103b-1T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103b-10T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GALH-103b-10THGSB
Basic UDI-DI: B-GALH-103b-10THGSB
Reference: GALH-103b-10T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103b-10T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GALH-103b-10THF
Basic UDI-DI: B-GALH-103b-10THF
Reference: GALH-103b-10T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103a-7T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GALH-103a-7TG2
Basic UDI-DI: B-GALH-103a-7TG2
Reference: GALH-103a-7T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103a-5T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GALH-103a-5THGNJ
Basic UDI-DI: B-GALH-103a-5THGNJ
Reference: GALH-103a-5T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103a-5T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GALH-103a-5TFU
Basic UDI-DI: B-GALH-103a-5TFU
Reference: GALH-103a-5T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103a-2T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GALH-103a-2THGMV
Basic UDI-DI: B-GALH-103a-2THGMV
Reference: GALH-103a-2T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103a-2T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GALH-103a-2TFK
Basic UDI-DI: B-GALH-103a-2TFK
Reference: GALH-103a-2T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details