Vitrosens Biyoteknoloji Anonim Şirketi

SRN: TR-MF-000026452 · SERIFALI MAH. SEHIT SK 17/A, 34775 İstanbul, Türkiye

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Basic UDI-DIs

520

Total Devices

520

On Market

520

Off Market

Certificates

Valid

Expiring < 6mo

Countries

Basic Information

Address: SERIFALI MAH. SEHIT SK 17/A, 34775 İstanbul, Türkiye
Email: [email protected]
Phone: +90 216 784 41 01
Website: vitrosens.com

Regulatory Overview

Regulation

Eu Ivdd 520

Classification

Eu Ivd General 517

Eu Ivd Self Testing 3

Device Types

Certificate Health

Total

Valid

Expiring < 6mo

Expired / Withdrawn

Certificates by Expiry Year

Type	Number	Notified Body	Legislation	Issue Date	Expiry Date	Status
IVDD Annex III Section 6	1435-IVDD-252/2022	POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.			May 27, 2025

Device Portfolio

Name	Regulation	Classification	Market Status
ChainFor Mycobacterium Tuberculosis Detection RT-qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Norovirus GI Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor SARS-CoV-2 & Flu & RSV Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
DrugFor™ MET Rapid Test Kit (Urine)	EU IVDD	Eu Ivd General	On Market
DrugFor™ Marijuana (THC) Rapid Test Kit (Urine)	EU IVDD	Eu Ivd General	On Market
DrugFor™ Opiate (OPI) Rapid Test Kit (Urine)	EU IVDD	Eu Ivd General	On Market
DrugFor™ Synthetic Cannabinoid (K2) Rapid Test Kit (Urine)	EU IVDD	Eu Ivd General	On Market
DrugFor™Benzodiazepines (BZO) Rapid Test Kit (Urine)	EU IVDD	Eu Ivd General	On Market
DrugFor™Methadone (MTD) Rapid Test Kit (Urine)	EU IVDD	Eu Ivd General	On Market
DrugFor™Saliva Multi-Drug Test Kit	EU IVDD	Eu Ivd General	On Market
ChainFor TTV Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor ABR ID-12 Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor ABR ID-23 Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Adenovirus Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Aeromonas + Yersinia enterocolitica Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Astrovirus Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Blastocystis hominis + Dientamoeba fragilis Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Bordetella pertussis Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor CCHFV Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor CNS & Tick Bourne Infection ID-32 Genotyping qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Campylobacter coli + C. lari + C. jejuni Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Campylobacter spp. Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Candida Albicans Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Candida Auris Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Chikungunya Virus Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Clostridium diﬀicile Binary Toxin A/B Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Clostridium diﬀicile Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Clostridium diﬀicile Toxin A Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Clostridium diﬀicile Toxin B Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Cryptosporidium Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Dengue Virus Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Dientamoeba fragilis Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor EHEC + EPEC + EIEC Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor ETEC + EIEC Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Entamoeba dispar Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Entamoeba histolytica Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Gardnerella vaginalis Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Gastroenteritis Bacterial Pathogen Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Gastroenteritis ID-24 Genotyping qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Gastroenteritis Parasitic Pathogen Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Gastroenteritis Viral Pathogen Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Genital Ulcer Genotyping Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor Giardia lamblia Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor HDV Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor HEV Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor HPV 16/18 Genotyping Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor HPV ID-14 Genotyping qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor HPV Screening ID-15 qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor HPV Screening ID-26 qPCR Kit	EU IVDD	Eu Ivd General	On Market
ChainFor HSV-1 Detection qPCR Kit	EU IVDD	Eu Ivd General	On Market

View all 520 devices →