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IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: Equinox Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018901
UDI-DI: D-RH-FSHFC
Basic UDI-DI: B-RH-FSHFC
Reference: RH-FSH-S, RH-FSH-C, RH-FSH-B
EMDN: W0102160301
EMDN description: FSH - 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

PRL 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-PRL-D06aNS
Basic UDI-DI: B-PRL-D06aNS
Reference: PRL-D06a
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

Premom Pregnancy Test

PMS-150

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-PMS-150Z7
Basic UDI-DI: B-PMS-150Z7
Reference: PMS-150
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

Premom Pregnancy Test

PMS-120

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-PMS-120YW
Basic UDI-DI: B-PMS-120YW
Reference: PMS-120
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

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

β-HCG 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-HCG-D06a82
Basic UDI-DI: B-HCG-D06a82
Reference: β-HCG-D06a
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

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

FSH 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-GKPD173XR
Basic UDI-DI: B-GKPD173XR
Reference: GKPD173
EMDN: W0102160301
EMDN description: FSH - 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

FSH / 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-GKPD172XP
Basic UDI-DI: B-GKPD172XP
Reference: GKPD172
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
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

FSH Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD143XG
Basic UDI-DI: B-GKPD143XG
Reference: GKPD143
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

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