Manufacturer

Pluslife

ChinaLegal entities : Guangzhou Pluslife Biotech Co., Ltd

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

EU representative : Medunion S.L. (Spain)

11 categories, 15 models including 15 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
Controls infectious immunology - RT & POC	W0105094001	Mycobacterium Tuberculosis Nucleic Acid Assay Control2 refs SARS-CoV-2/Influenza A/Influenza B/RSV Nucleic Acid Assay Control98/79 Strep A Nucleic Acid Assay Control CRM1010402-198/79	C IVDR, 98/79	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	MiniDock Ultra PM001 Ultra Pluslife Dock Pro 8 PM008	A IVDR	EUDAMED record Report an error
Other virus combinations - multiplex NA reagents	W0105070302	Pluslife SARS-CoV-2/Influenza A/Influenza B Card SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Test Card98/79 SARS-CoV-2/Influenza A/Influenza B/RSV Nucleic Acid Test Card98/79	– 98/79	EUDAMED record Report an error
Coronavirus - NA reagents	W0105041106	Pluslife SARS-CoV-2 Card SARS-CoV-2 Nucleic Acid Testing Card98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	Influenza A/Influenza B/RSV Nucleic Acid Test Card98/79	– 98/79	EUDAMED record Report an error
Mycobacterial detection by NA reagents	W0105010703	MiniDock MTB Test	C IVDR, 98/79	EUDAMED record Report an error
Mycoplasma pneumoniae detection by NA reagents	W010501080301	Pluslife Mycoplasma Pneumoniae Card98/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing apparatuses - rapid and point of care tests	W02050301	Mini Dock PM001	A IVDR	EUDAMED record Report an error
Respiratory syncytial virus (rsv)	W0105040605	Pluslife RSV Card98/79	– 98/79	EUDAMED record Report an error
Strep. a detection by NA reagents	W0105011103	Pluslife Strep A Card98/79	– 98/79	EUDAMED record Report an error
Various general purpose IVD instruments - hardware accessories	W02079080	WD002	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.