We are pleased to announce that Ecoli Dx has received and officially published a Notified Body Confirmation Letter issued by 3EC International a.s. (Notified Body 2265), marking an important milestone in the transition of our eSens PCR product line to the European In Vitro Diagnostic Regulation (IVDR).
The document confirms that 3EC International has received our formal application for IVDR conformity assessment and that a written agreement has been signed for the eSens PCR kits listed in the confirmation letter.
What does this mean for our customers and distributors?
The listed eSens products, classified as Class C, which form the most significant part of our business, can continue to be placed on the EU market as CE-marked legacy IVD devices until 31 December 2028, under the transitional provisions of Regulation (EU) 2017/746, as amended by Regulation (EU) 2024/1860, provided all applicable regulatory conditions continue to be met.
This achievement represents a significant step towards full IVDR certification and supports the continued availability of the eSens product line for clinical laboratories across Europe as well as beyond EU where CE IVD is part of the regulatory needs.
The confirmation applies specifically to the products listed in the document. Other eSens products may have different regulatory statuses.
- ES3000A eSens Neisseria gonorrhoeae QL PCR kit
- ES3001A eSens Treponema pallidum QL PCR kit
- ES3002A eSens Trichomonas vaginalis QL PCR kit
- ES3003A eSens Mycoplasma genitalium QL PCR kit
- ES3004A eSens Mycoplasma hominis QL PCR kit
- ES3005A eSens Gardnerella vaginalis QL PCR kit
- ES3007A eSens Ureaplasma sp. QL PCR kit
- ES3009B eSens M.genitalium ML/FQ resistance QT
PCR kit
- ES3040A eSens Ureaplasma parvum/urealyticum QL
PCR kit
- ES3043A eSens Gardnerella
vaginalis/Lactobacillus sp. QT PCR kit
- ES3044A eSens Florocenosis/Bacterial Vaginosis
QT PCR kit
- ES3045A eSens Florocenosis/Mycoplasmas QT PCR
kit
- ES3047A eSens Florocenosis/Aerobes QT PCR kit
- ES3048A eSens Ureaplasma/M.genitalium/M.hominis
QL PCR kit
- ES3050A eSens N.gonorrhoeae/M.genitalium/T.vaginalis
QL PCR kit
- ES3080A eSens HPV HR 14 screen/16,18,45 genotype
QT PCR kit
- ES3081A eSens HPV HR 14 genotype QT PCR kit
- ES3082A eSens HPV HR 16/18 genotype QT PCR kit
- ES3090A eSens HPV LR 6/11 genotype QL PCR kit
- ES3100B eSens HAV QL PCR kit
- ES3112B eSens HBV genotype QL PCR kit
- ES3122B eSens HCV genotype QL PCR kit
- ES3201A eSens HSV 1/2 genotype QL PCR kit
- ES3202B eSens VZV QL PCR kit
- ES3203A eSens EBV QT PCR kit
- ES3206A eSens HHV6 QT PCR kit
- ES3207A eSens HHV7 QT PCR kit
- ES3208A eSens HHV8 QT PCR kit
- ES3240A eSens EBV/HHV6 QT PCR kit
- ES3304A eSens ARVI screen QL PCR kit
- ES3400B eSens Enterovirus QL PCR kit
- ES3401B eSens Poliovirus QL PCR kit
- ES3441A eSens JCV/BKV QT PCR kit
- ES3801B eSens Parvovirus B19 QT PCR kit
- ES3300A eSens Bordetella
pertussis/bronchiseptica/parapertussis QL PCR kit
- ES3305B eSens MTC QL PCR kit
- ES3306B eSens MDR MTC QL PCR kit
- ES3307B eSens Legionella pneumophila QT PCR kit
- ES3308A eSens Corynebacterium diphtheriae/tox
genes QL PCR kit
- ES3309B eSens Mycobacterium
tuberculosis/bovis/BCG QL PCR kit
- ES3402B eSens Listeria monocytogenes QT PCR kit
- ES3440B eSens
N.meningitidis/H.influenzae/S.pneumoniae QL PCR kit
- ES3541B eSens Acute intestinal infections QL PCR
kit
- ES3542B eSens Escherichioses QL PCR kit
- ES3803B eSens Pneumocystis jirovecii QL PCR kit
- ES3804A eSens Cryptococcus neoformans QL PCR kit
- ES3808B eSens Leptospira QL PCR kit
- ES3809A eSens Streptococcus agalactiae QT PCR
kit
- ES3810A eSens Streptococcus pyogenes QT PCR kit
- ES4300A eSens MRSA QT PCR kit
- ES3601B eSens Dengue virus type QL PCR kit
- ES3602B eSens WNV QL PCR kit
- ES3605B eSens Zika virus QL PCR kit
- ES3701B eSens Borrelia miyamotoi QL PCR kit
- ES3740A eSens TBEV/Borrelia/Anaplasma/Ehrlichia
QL PCR kit
- ES4301A eSens MDR MBL QL PCR kit
- ES4302A eSens MDR KPC/OXA QL PCR kit
- ES4303A eSens MDR VRE QL PCR kit
- ES4304A eSens MDR MCR-1 QL PCR kit
View and download the official Notified Body Confirmation Letter
