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81 device results listed.

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ZuhauseTEST FSH Rapid Test Midstream

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 04260173433951
Basic UDI-DI: B-04260173433951
Reference: FFS-103H
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-W52-SVQ

One Step FSH Urine Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W52-SVQ
Basic UDI-DI: B-W52-SVQ
Reference: W52-S
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-W52-MVC

One Step FSH Urine Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W52-MVC
Basic UDI-DI: B-W52-MVC
Reference: W52-M
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-W52-CUQ

One Step FSH Urine Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W52-CUQ
Basic UDI-DI: B-W52-CUQ
Reference: W52-C
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:29

Manufacturer products Authorised representative products Authorised representative actors View details

DAVID

strip, cassette, midstream

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

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 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

FSH 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-FSH-D06aFR
Basic UDI-DI: B-FSH-D06aFR
Reference: FSH-D06a
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 22:12

Manufacturer products Authorised representative products Authorised representative actors View details

FSH One Step Menopause Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-FSH-A02aEQ
Basic UDI-DI: B-FSH-A02aEQ
Reference: FSH-A02a
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 22:12

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Quantitative Test Kit (Time-Resolved FIA)

FAFSH-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FAFSH-402aXU
Basic UDI-DI: B-FAFSH-402aXU
Reference: FAFSH-402a
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Quantitative Test Kit (Time-Resolved FIA)

FAFSH-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FAFSH-402aHGW6
Basic UDI-DI: B-FAFSH-402aHGW6
Reference: FAFSH-402a
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-FA0020YW

50T/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0020YW
Basic UDI-DI: B-FA0020YW
Reference: 52027075
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000054349
UDI-DI: D-CNMF000054349YS003Q2
Basic UDI-DI: B-CNMF000054349YS003Q2
Reference: YS003
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:09

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNM0000180726003N4

Strip, Cassette, Midstream and Urine Cup

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: Shanghai Chemtron Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018072
UDI-DI: D-CNM0000180726003N4
Basic UDI-DI: B-CNM0000180726003N4
Reference: 6003C 6003S 6003D 6003B
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Romania
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

D-808184QU

FSH Rapid Detect

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808184QU
Basic UDI-DI: B-808184QU
Reference: 808184
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-808122Q6

FSH Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808122Q6
Basic UDI-DI: B-808122Q6
Reference: 808122
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-300220LE

Menopause

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-300220LE
Basic UDI-DI: B-300220LE
Reference: 300220
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.07.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

FSH Test (FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763617
Basic UDI-DI: B-15065023763617
Reference: TV20023
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:36

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

FSH One Step Menopause Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763310
Basic UDI-DI: B-15065023763310
Reference: TV10032
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

08693285181681

Menopause (FSH) Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181681
Basic UDI-DI: B-08693285181681
Reference: IFSH02
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:26

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