Manufacturer

Pilotgene

ChinaLegal entities : Pilot Gene Technology (Hangzhou) Co., Ltd

Markets : Italy

Approvals : EU – class A

EU representative : Medunion S.L. (Spain)

13 categories, 23 models including 23 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
Multiple infectious - multiplex assays - other	W0105070599	MP0298/79 P0998/79 Twenty Bloodstream Pathogenic Microorganisms and Drug Resistance Genes Detection Kit (Digital PCR Method） MP02-P98/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	Automated Digital PCR System AD3207 Digital PCR Workstation DW3200 Integrated Digital PCR Instrument Pilot1200	A IVDR	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Nucleic Acid Extraction or Purification Reagent CF12 refs Nucleic Acid Extraction or Purification Reagent Easy-CF2 Nucleic Acid Extraction or Purification Reagent TF1	A IVDR	EUDAMED record Report an error
Blood stream infection/sepsis (bacteria & fungi) - multiplex NA reagents	W0105070202	FS98/79 P1198/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - consumables	W02050185	Magnetic Rod Sleeve Microfluidic Chip V3.02 refs	A IVDR	EUDAMED record Report an error
Pipettes, tips without filter	W0503020202	Tip Tip Box TIP-P-3-4	A IVDR	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	RP0198/79 TB0198/79	– 98/79	EUDAMED record Report an error
DNA genomic preparation devices	W02050106	Automated Nucleic Acid Detection Reaction Construction System AP10	A IVDR	EUDAMED record Report an error
Gram+ - gram- - fungi - multiplex NA reagents	W0105070201	SC98/79	– 98/79	EUDAMED record Report an error
Meningitis / encephalitis infections - multiplex NA reagents	W0105070505	EM98/79	– 98/79	EUDAMED record Report an error
Other multiple infectious - multiplex NA reagents	W0105070502	MP2198/79	– 98/79	EUDAMED record Report an error
Other virus combinations - multiplex NA reagents	W0105070302	HHV98/79	– 98/79	EUDAMED record Report an error
Supplemental NA reagents	W0105900103	Digital PCR Universal Kit dPCR	A IVDR	EUDAMED record Report an error

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