Manufacturer

HEALSTONE Biotech

CanadaLegal entities : HEALSTONE Biotech Inc.

Markets : Germany · United States

Approvals : United States (FDA) – 510(k) : 3 · class I, II · latest in 2022 · see on the FDA website

EU representative : CMC Medical Devices & Drugs SL (Spain)

sales@orientgene.com

22 categories, 37 models including 37 on the market, 1 country

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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
Coronavirus - NA reagents	W0105041106	SARS-CoV-2 & Influenza A/B Detection Kit (Direct Fluorescence PCR) ACAB0298/79 SARS-CoV-2 Detection Kit (Direct Fluorescence PCR) ACOV0198/79 SARS-CoV-2 Detection Kit (Direct Fluorescence PCR) ACOV0298/79 SARS-CoV-2 Detection Kit (Fluorescence RT-PCR) ACOV0398/79 SARS-CoV-2 K417N/E484K Mutations Detection Kit (Fluorescence PCR) ACOV0598/79 2 others SARS-CoV-2 N501Y/HV69-70del Mutations Detection Kit (Fluorescence PCR) ACOV0498/79 Vaginal pH Rapid Test Cassette (Swab) VPH-502a98/79	– 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Dengue IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(ab)-402c98/79 Dengue NS1 Ag Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(NS)-402c98/79 Dengue NS1 Ag Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(NS)-402d98/79 Dengue NS1+IgM/IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN-425a98/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	H. pylori Ab Rapid Test Cassette (Serum/Plasma) GCHP-302a98/79 H. pylori Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) GCHP-402a98/79 H. pylori Ag Rapid Test Cassette (Feces) GCHP-602a98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	Rapid Respiratory Syncytial Virus RNA Test RRSV0198/79 SARS-CoV-2 & Influenza A/B Detection Kit (Direct Fluorescence PCR) ACAB0198/79 SARS-CoV-2 & Omicron Variants Detection Kit (Fluorescence PCR) ACOV0898/79	– 98/79	EUDAMED record Report an error
Chikungunya virus	W0105040625	Chikungunya IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCHK(IgM)-402a98/79 One Step Chikungunya Ag Test Cassette (Whole Blood/Serum/Plasma) GCCHK-402a98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pv)-402a98/79 Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pan)-402a98/79	– 98/79	EUDAMED record Report an error
Adenovirus - NA reagents	W0105040501	Ocular viral Detection Kit (Fluorescence PCR) AOPV0198/79	– 98/79	EUDAMED record Report an error
Bacteriology - NA reagents - other	W0105011699	Rapid mycoplasma pneumoniae DNA test RMP0198/79	– 98/79	EUDAMED record Report an error
Coronavirus antibody (ab) - RT & POC	W0105090502	One Step Microalbumin Test Cassette (Urine) GIHSA-102a98/79	– 98/79	EUDAMED record Report an error
Cryptococcus	W0105060303	Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid) GCCr(Ag)-402a98/79	– 98/79	EUDAMED record Report an error
Gonococcal antigen detection	W0105010201	Gonorrhea Rapid Test Cassette (Swab) GCGON-502b98/79	– 98/79	EUDAMED record Report an error
Hav antibody (total)	W0105020102	HAV IgM Rapid Test Cassette (Serum/Plasma) GCHAV(IgM)-302Ba98/79	– 98/79	EUDAMED record Report an error
HPV antigen / antibodies	W0105041001	Human Papillomavirus E7 Protein Rapid Test Cassette (Swab) GCHPV-502a98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Rapid SARS-CoV-2 RNA test RCOV0198/79	– 98/79	EUDAMED record Report an error
Mycobacterial antibody assays	W0105010702	Tuberculosis IgG/IgM Rapid Test Cassette (Serum/Plasma) GCTB-302a98/79	– 98/79	EUDAMED record Report an error
Mycoplasma pneumoniae detection by NA reagents	W010501080301	Rapid Influenza A/B RNA test RFLU0198/79	– 98/79	EUDAMED record Report an error
Other coronavirus - RT & POC	W0105090599	Human Parainfluenza Virus Type I / III and Adenovirus Detection Kit (Fluorescence PCR) APA0198/79	– 98/79	EUDAMED record Report an error
Respiratory syncytial virus (rsv) - NA reagents	W0105040505	Rapid Human Adenovirus DNA Test RADV0198/79	– 98/79	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	Influenza A/ B and Respiratory Syncytial Virus Detection Kit (Fluorescence PCR) AFR0198/79	– 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	Syphilis Ab Rapid Test Cassette (Serum/Plasma) GCSYP-302a98/79	– 98/79	EUDAMED record Report an error
Virology - NA reagents - other	W0105040599	Ocular Bacteria and Fungi Detection Kit (Fluorescence PCR) AOBF0198/79	– 98/79	EUDAMED record Report an error
Zika virus	W0105040630	Zika NS1 Ag Rapid Test Cassette (Whole blood/Serum/Plasma) GCZIK(NS1)-402a98/79	– 98/79	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.

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