Manufacturer

Bioneer

South KoreaLegal entities : BIONEER Corporation

First countries of placing on the market declared in EUDAMED : Germany

EU representative : Medical Technology Promedt Consulting GmbH (Germany)

6 categories, 34 models including 34 on the market, 1 country

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	AccuPrep® Dx Viral RNA Extraction Kit ExiPrep ™ 48 Viral RNA Kit ExiPrep™48 Viral RNA Kit ExiPrep™ 48 Genomic DNA Kit ExiPrep™48 Genomic DNA Kit ExiPrep™ 48 SF Genomic DNA Kit ExiPrep™ 48 SF Mycobacteria Genomic DNA Kit 15 others ExiPrep™ 48 SF Viral DNA/RNA Kit ExiPrep™ 48 Viral DNA/RNA Kit ExiPrep™ 96 Genomic DNA Kit ExiPrep™ 96 Viral DNA/RNA Kit ExiPrep™ Dx Bacteria Genomic DNA Kit ExiPrep™ Dx Blood Genomic DNA Kit ExiPrep™ Dx Blood Viral DNA Kit ExiPrep™ Dx Mycobacteria Genomic DNA Kit ExiPrep™ Dx SF Mycobacteria Genomic DNA Kit ExiPrep™ Dx Viral DNA Kit ExiPrep™ Dx Viral DNA/RNA Kit ExiPrep™ Dx Viral RNA Kit ExiStation™ FA DNA/RNA Kit (V2) ExiStation™ FA DNA/RNA Kit (V3) MagListo™ 5M Viral DNA/RNA Extraction Kit	A IVDR	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	Exicycler™ 962 refs ExiCycler™ V5 3843 refs ExiPrep™16 Dx ExiPrep™48 Dx ExiPrep™96 Lite 2 others ExiStation™ FA 384 ExiStation™ FA 96/3842 refs IRON-qPCR™	A IVDR	EUDAMED record Report an error
Virology - NA reagents - other	W0105040599	AccuPower® RV Kit (ExiStation™ FA 96) AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit IRON-qPCR™ RV Kit	B IVDR	EUDAMED record Report an error
HIV 1 - NA reagents	W0105030107	AccuPower® HIV-1 Quant Kit (ExiStation™ FA 96) AccuPower® HIV-1 Quantitative RT-PCR Kit98/79	D IVDR, 98/79	EUDAMED record Report an error
Hepatitis b virus - NA reagents	W0105020216	AccuPower® HBV Quant Kit (ExiStation™ FA 96)	D IVDR	EUDAMED record Report an error
Hepatitis c virus - NA reagents	W0105020307	AccuPower® HCV Quant Kit (ExiStation™ FA 96)	D IVDR	EUDAMED record Report an error

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