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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

TruVue

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

TruVue

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

Earlibird®

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

Earlibird®

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

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

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

GE5 PREGNANCY TEST KIT

PREGNANCY TEST KIT

IVD self-testing devicesIVDDOn the marketSelf testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616169
Basic UDI-DI: B-08697962616169
Reference: GE5HCG-C
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 ULTRA EARLY PREGNANCY TEST KIT

SOFTEC Ultra Early Pregnancy Test Kit

IVD self-testing devicesIVDDOn the marketSelf testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616091
Basic UDI-DI: B-08697962616091
Reference: SFTHCG-M
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 Pregnancy Test Kit

IVD self-testing devicesIVDDOn the marketSelf testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616084
Basic UDI-DI: B-08697962616084
Reference: SFTHCG-C
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

IND ULTRA EARLY MIDSTREAM PREGNANCY TEST

ULTRA EARLY MIDSTREAM 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: 08697962109067
Basic UDI-DI: B-08697962109067
Reference: INDHCG-M
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

08693285187775

Pregnancy (hCG) Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187775
Basic UDI-DI: B-08693285187775
Reference: TIHCG06001
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:33

Manufacturer products View details

08693285187768

Pregnancy (hCG) Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187768
Basic UDI-DI: B-08693285187768
Reference: TIHCG03001
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:33

Manufacturer products View details

08693285187409

Pregnancy (hCG) Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187409
Basic UDI-DI: B-08693285187409
Reference: TIHCG03010
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:32

Manufacturer products View details

08693285187157

Pregnancy (hCG) Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187157
Basic UDI-DI: B-08693285187157
Reference: TIHCG03
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:32

Manufacturer products View details