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EUDAMED Device Search

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

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05.08.2026 02:00

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LH Test (FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763600
Basic UDI-DI: B-15065023763600
Reference: TV20022
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:35

Manufacturer products Authorised representative products Authorised representative actors View details

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

LH One Step Ovulation Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763303
Basic UDI-DI: B-15065023763303
Reference: TV10031
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Czechia
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

LH One Step Ovulation Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763297
Basic UDI-DI: B-15065023763297
Reference: TV10030
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

HCG One Step Pregnancy Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763280
Basic UDI-DI: B-15065023763280
Reference: TV10029
EMDN: W0102160302
EMDN description: HCG - 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

HCG One Step Pregnancy Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763273
Basic UDI-DI: B-15065023763273
Reference: TV10028
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Czechia
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

HCG One Step Pregnancy Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763266
Basic UDI-DI: B-15065023763266
Reference: TV10027
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Malta
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

Fortel Ultra Sensitive Pregnancy Midstream 1-Test

1147-01

IVD self-testing devicesIVDDOn the marketAnimal tissuesHuman tissuesKitSelf testingSingle use

Manufacturer: BIOEUROPE GmbH
Manufacturer SRN: DE-MF-000039230
UDI-DI: D-1147-01V2
Basic UDI-DI: B-1147-01V2
Reference: 1147-01
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 05:50

Manufacturer products View details

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 04260457778402
Basic UDI-DI: 69360201208J
Reference: HCG-EB-03-1tP
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 04260457778433
Basic UDI-DI: 6936020120BRB
Reference: HCG10-EB-03-1tP
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

Zwangerschapstest Digitaal Ultravroeg

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesInstrumentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08700216299947
Basic UDI-DI: 4084500CB15QV
Reference: 08700216299947
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 11.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

BioSign hCG Serum/Urine card

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Princeton BioMeditech Corporation
Manufacturer SRN: US-MF-000048310
UDI-DI: 10743816000655
Basic UDI-DI: B-10743816000655
Reference: BSP-120S-35
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 11.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

Maybe Baby

IVD self-testing devicesIVDDOn the marketSelf testing

Manufacturer: OPTIX DOO BEOGRAD-ZEMUN
Manufacturer SRN: RS-MF-000031651
UDI-DI: 09317039000460
Basic UDI-DI: B-09317039000460
Reference: MB 00.00.00
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Northern Ireland
Authorised representative: Salus Cons Kft.
Last updated: 10.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Těhotenský test s ukazatelem týdnů

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesInstrumentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 04084500759817
Basic UDI-DI: 4084500CB985
Reference: 04084500759817
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 09.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

Clearblue Ovulatietest Geavanceerd Digitaal

ADOT

IVD self-testing devicesIVDDOn the marketAnimal tissuesInstrumentReagentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08700216300056
Basic UDI-DI: B-08700216300056
Reference: 08700216300056
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Belgium
Authorised representative: MDSS GmbH
Last updated: 09.07.2026 18:34

Manufacturer products Authorised representative products Authorised representative actors View details

IND ONE STEP HCG RAPID PREGNANCY TEST

ONE STEP HCG RAPID PREGNANCY TEST

IVD self-testing devicesIVDDOn the marketSelf testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962617340
Basic UDI-DI: B-08697962617340
Reference: SFTHCG-M
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:22

Manufacturer products View details

BEBE TIME PREGNANCY TEST

STRİP

IVD self-testing devicesIVDDOn the marketSelf testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616527
Basic UDI-DI: B-08697962616527
Reference: STRİP
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:22

Manufacturer products View details

BIG KIT One Step Human Chorionic Gonadotropin (hCG) Pregnancy Test

Cassette

IVD self-testing devicesIVDDOn the marketSelf testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616374
Basic UDI-DI: B-08697962616374
Reference: BKHCG
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:22

Manufacturer products View details

BEBE TIME PREGNANCY TEST

cassette

IVD generalIVDDOn the marketSelf testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616367
Basic UDI-DI: B-08697962616367
Reference: BEBE TIME
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:21

Manufacturer products View details

SOFTEC LH Ovulation Rapid Test Midstream

LH Ovulation Rapid Test Midstream

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616190
Basic UDI-DI: B-08697962616190
Reference: SFTLH-M
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:21

Manufacturer products View details