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28 device results listed.

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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

SOFTEC Dengue NS1 Rapid Test Kit

Dengue NS1 Rapid Test Kit

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616732
Basic UDI-DI: B-08697962616732
Reference: SFDNNS1
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:22

Manufacturer products View details

SOFTEC Dengue NS1/IgG/IgM Combo Rapid Test Kit

SFDNCB40

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616725
Basic UDI-DI: B-08697962616725
Reference: SFDNCB
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:22

Manufacturer products View details

SOFTEC Malaria P.f/P.v Rapid Test Kit

Malaria P.f/P.v Rapid Test Kit

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616718
Basic UDI-DI: B-08697962616718
Reference: SFMPFPV
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:22

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SOFTEC Human Papillomavirus (HPV) High Risk Panel Qualitative RT-qPCR Detection Kit

TUBE

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616596
Basic UDI-DI: B-08697962616596
Reference: ZT-HPV-01-100
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:22

Manufacturer products View details

SOFTEC Herpes Simplex Virus (HSV-1 & HSV-2) Qualitative RT-qPCR Detection Kit

ZT-HSV-01-100

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616541
Basic UDI-DI: B-08697962616541
Reference: ZT-HSV-01-100
EMDN: W0105040399
EMDN description: HSV REAGENTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 09.07.2026 07:22

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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 Syphilis Rapid Test Kit (Cassette)

SFSPRT40

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616350
Basic UDI-DI: B-08697962616350
Reference: SFSPRT
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:21

Manufacturer products View details

SOFTEC Magic-Auto Whole Blood DNA/RNA Isolation Kit

ZT-MAWB

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616343
Basic UDI-DI: B-08697962616343
Reference: ZT-MAWB-01-96
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:21

Manufacturer products View details

SOFTEC SARS-CoV-2 Antigen Rapid Test Kit (Nasal Swab)

SFSCAGN1

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616312
Basic UDI-DI: B-08697962616312
Reference: ZET01N
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:21

Manufacturer products View details

SOFTEC Tuberculosis Rapid Test Kit

SFTB40

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616305
Basic UDI-DI: B-08697962616305
Reference: SFTB
EMDN: W0105010702
EMDN description: MYCOBACTERIAL ANTIBODY ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:21

Manufacturer products View details

SOFTEC Creatine Kinase-MB Rapid Test Kit

SFCKMB40

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616299
Basic UDI-DI: B-08697962616299
Reference: SFCKMB
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:21

Manufacturer products View details

SOFTEC Hepatitis E Virus (HEV) IgG/IgM Rapid Test Kit

SFHEV40

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616282
Basic UDI-DI: B-08697962616282
Reference: SFHEV
EMDN: W0105020503
EMDN description: HEV ANTIBODY (TOTAL)
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:21

Manufacturer products View details

SOFTEC Troponin I Rapid Test Kit

SFTPI40

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616275
Basic UDI-DI: B-08697962616275
Reference: SFTPI
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:21

Manufacturer products View details

SOFTEC H.Pylori Antigen test

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616268
Basic UDI-DI: B-08697962616268
Reference: SFTHPAG
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:21

Manufacturer products View details

SOFTEC SARS-CoV-2 Antigen Rapid Test (Nasal Swab)

SARS-CoV-2 Antigen Rapid Test (Nasal Swab)

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616213
Basic UDI-DI: B-08697962616213
Reference: ZET01N
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:21

Manufacturer products View details

SOFTEC SARS-CoV-2 Neutralizing Antibody Rapid Test

SARS-CoV-2 Neutralizing Antibody Rapid Test

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616206
Basic UDI-DI: B-08697962616206
Reference: SFTNAB-1
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - 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