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Norgen Biotek Corporation

Canada·CA-MF-000024034

Last updated September 18, 2026

About

Norgen Biotek was founded in 1998 by Dr. Yousef Haj-Ahmad, MSc, PhD. Norgen is an ISO 9001, ISO 13485 and ISO 15189 certified fully-integrated biotechnology company that provides comprehensive research services to the scientific community such as Next Generation Sequencing, Nucleic Acid Extraction . Norgen's ISO certifications indicate our commitment to manufacturing and selling high quality products, as well as our commitment to continually improving our company, our products and our quality management system.

From the manufacturer's own website. Source

Information

Country: Canada
Address: 3430, Schmon Parkway, Thorold, Canada
Website: norgenbiotek.com
LinkedIn: linkedin.com/company/norgenbiotek
Facebook: facebook.com/norgenbiotek
Email: [email protected]
Phone: 9052278848
PRRC Contact: Alexandra Kachura
EUDAMED SRN: CA-MF-000024034
FDA FEI Number: —
DUNS Number: —

Catalogue (23)

Device	Model / Reference	Registries	Class	Status
Total RNA Purification Kit Dx	Dx24350	EUDAMED	Class A	Active
FFPE RNA Purification Kit Dx	Dx25300	EUDAMED	Class A	Active
Saliva DNA Isolation Kit Dx	Dx45400	EUDAMED	Class A	Active
Urine DNA Isolation Kit Dx	Dx48800	EUDAMED	Class A	Active
FFPE DNA Purification Kit Dx	Dx47400	EUDAMED	Class A	Active
Saliva RNA Collection and Preservation Devices Dx	53800	EUDAMED	Class A	Active
cf-DNA/cf-RNA Preservative Tubes Dx	Dx63950	EUDAMED	IVD General	Active
Plasma/Serum Cell-Free Circulating Purification Kit Dx	Dx55800	EUDAMED	Class A	Active
Stool Total RNA Purification Kit Dx	Dx49500	EUDAMED	Class A	Active
EZCollect Saliva DNA Device Dx	69900	EUDAMED	Class A	Active
EZCollect Saliva RNA Device Dx	69800	EUDAMED	Class A	Active
Total Nucleic Acid Preservation Tubes Dx	Dx69200	EUDAMED	Class A	Active
Saliva/Swab RNA Purification Kit Dx	Dx69300	EUDAMED	Class A	Active
Blood Genomic DNA Isolation Mini Kit Dx	Dx46300	EUDAMED	Class A	Active
Plasma/Serum Circulating and Exosomal RNA Purification Kit Dx (Slurry Format)	Dx42800	EUDAMED	Class A	Active
Saliva DNA Collection and Preservation Devices Dx	49000	EUDAMED	Class A	Active
Urine Total RNA Purification Maxi Kit Dx (Slurry Format)	Dx29600	EUDAMED	Class A	Active
Stool Nucleic Acid Collection and Preservation Devices Dx	Dx45660	EUDAMED	Class A	Active
Total RNA Purification Kit Dx	Dx24380	EUDAMED	Class A	Active
Plasma/Serum Cell-Free Circulating Purification Kit Dx	Dx55500	EUDAMED	Class A	Active
FFPE RNA/DNA Purification Plis Kit	Dx54300	EUDAMED	Class A	Active
Plasma/Serum Circulating DNA Purification Mini Kit Dx (Slurry Format)	Dx50600	EUDAMED	Class A	Active
Stool DNA Isolation Kit Dx	Dx27600	EUDAMED	Class A	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

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