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EUDAMED Device Search

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

Last updated

01.08.2026 09:11

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73 device results listed.

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Follicle-Stimulating Hormone Test

FSH-U11, FSH-U23, FSH-U35

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804816773
Basic UDI-DI: B-06952804816773
Reference: FSH-U11 FSH-U23 FSH-U35
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

FSH-W23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804803230
Basic UDI-DI: B-06952804803230
Reference: FSH-W23F3
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:24

Manufacturer products Authorised representative products Authorised representative actors View details

25T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334808626
Basic UDI-DI: B-06950334808626
Reference: 52026072
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:40

Manufacturer products Authorised representative products Authorised representative actors View details

Clairivo Menopauze zelftest

Midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Core Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023522
UDI-DI: 06942468170748
Basic UDI-DI: B-06942468170748
Reference: ACK21005-M01-002
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Netherlands
Authorised representative: Wellkang Ltd
Last updated: 26.06.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289810395
Basic UDI-DI: B-06933289810395
Reference: W245
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Rapid Quantitative Test

-

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208432
Basic UDI-DI: B-06933260208432
Reference: BT2205
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205585
Basic UDI-DI: B-06933260205585
Reference: BT0503005
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205578
Basic UDI-DI: B-06933260205578
Reference: BT0503004
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205561
Basic UDI-DI: B-06933260205561
Reference: BT0503003
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205554
Basic UDI-DI: B-06933260205554
Reference: BT0503002
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205547
Basic UDI-DI: B-06933260205547
Reference: BT0503001
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

Atlas Home Menopause Midstream

-

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Atlas Medical GmbH
Manufacturer SRN: DE-MF-000029961
UDI-DI: 04260658550326
Basic UDI-DI: B-04260658550326
Reference: 70178001
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 03:33

Manufacturer products View details

Atlas Home Menopause Cassette

-

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Atlas Medical GmbH
Manufacturer SRN: DE-MF-000029961
UDI-DI: 04260658550319
Basic UDI-DI: B-04260658550319
Reference: 70177001
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 03:33

Manufacturer products View details