Manufacturer

Norgen Biotek

CanadaLegal entities : Norgen Biotek Corporation

Markets : Netherlands

Approvals : EU – class A, B

EU representative : Emergo Europe B.V. (Netherlands)

Website regulatory@norgenbiotek.com

11 categories, 28 models including 28 on the market, 1 country

Export to CSV

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Blood Genomic DNA Isolation Mini Kit Dx FFPE DNA Purification Kit Dx FFPE RNA Purification Kit Dx FFPE RNA/DNA Purification Plis Kit Plasma/Serum Cell-Free Circulating Purification Kit Dx3 refs 9 others Plasma/Serum Circulating and Exosomal RNA Purification Kit Dx (Slurry Format) Plasma/Serum Circulating DNA Purification Mini Kit Dx (Slurry Format) Saliva DNA Isolation Kit Dx Saliva/Swab RNA Purification Kit Dx2 refs Stool DNA Isolation Kit Dx Stool Total RNA Purification Kit Dx Total RNA Purification Kit Dx3 refs Urine DNA Isolation Kit Dx Urine Total RNA Purification Maxi Kit Dx (Slurry Format)	A IVDR	EUDAMED record Report an error
Saliva collection devices	W05019002	EZCollect Saliva DNA Device Dx EZCollect Saliva RNA Device Dx Saliva DNA Collection and Preservation Devices Dx Saliva RNA Collection and Preservation Devices Dx	A IVDR	EUDAMED record Report an error
Faeces collection devices	W05019001	EZ Collect Stool Nucleic Acid Collection and Preservation Device Dx Stool Nucleic Acid Collection and Preservation Devices Dx	A IVDR	EUDAMED record Report an error
Bacteriology - NA reagents - other	W0105011699	Bacillus cereus TaqMan PCR Kit Dx	B IVDR	EUDAMED record Report an error
Cryptosporidium - NA reagents	W0105050307	Cryptosporidium TaqMan RT-PCR Kit Dx	B IVDR	EUDAMED record Report an error
Ebv - NA reagents	W0105040403	EBV TaqMan PCR Kit Dx	B IVDR	EUDAMED record Report an error
Giardia lamblia - NA reagents	W0105050308	Giardia intestinalis TaqMan RT-PCR Kit Dx	A IVDR	EUDAMED record Report an error
Jc virus - NA reagents	W0105040523	JCV TaqMan PCR Kit Dx	B IVDR	EUDAMED record Report an error
Norovirus - NA reagents	W0105040516	NoV TaqMan RT-PCR Kit Dx	B IVDR	EUDAMED record Report an error
Samples collection devices - other	W05019099	Dx6395098/79	– 98/79	EUDAMED record Report an error
Urine collection, tubes	W05010202	Urine Nucleic Acid Collection and Preservation System Dx	A IVDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.