Manufacturer

Operon

SpainLegal entities : OPERON, S.A.

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

22 categories, 39 models including 39 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
Virology - RT & POC - other	W0105099099	Simple Norovirus / Stick Norovirus 9.041.XXX.YY.ZZZ3 refs Simple RespirAdeno 9.091.XXX.YY.ZZZ3 refs SIMPLE ROTA-ADENO / STICK ROTA-ADENO 9.024.XXX.YY.ZZZ3 refs Simple Rota-Adeno-Noro 9.050.XXX.YY.ZZZ3 refs Simple Rotavirus / Stick Rotavirus 9.333.XXX.YY.ZZZ98/79 1 other Simple RSV-RespirAdeno 9.110.XXX.YY.ZZZ3 refs	B IVDR, 98/79	EUDAMED record Report an error
Parasites - RT & POC - other	W0105090499	SIMPLE CRYPTO / STICK CRYPTO 9.022.XXX.YY.ZZZ98/79 SIMPLE CRYPTO-GIARDIA / STICK CRYPTO-GIARDIA 9.023.XXX.YY.ZZZ98/79 Simple Crypto-Giardia-Entamoeba 9.144.XXX.YY.ZZZ3 refs SIMPLE ENTAMOEBA / STICK ENTAMOEBA 9.143.XXX.YY.ZZZ98/79 SIMPLE GIARDIA / STICK GIARDIA 9.019.XXX.YY.ZZZ98/79	B IVDR, 98/79	EUDAMED record Report an error
Bacteriology controls - inf.imm.	W0105080801	CONTROL POSITIVO EN SECO CAMPYLOBACTER / CAMPYLOBACTER DRY POSITIVE CONTROL 9.230.XXX.12.ZZZ98/79 CONTROL POSITIVO EN SECO GDH-TOXINS / DRY GDH-TOXINS POSITIVE CONTROL 9.065.XXX.12.ZZZ CONTROL POSITIVO EN SECO H.PYL-TF \|\| H.PYL-TF DRY POSITIVE CONTROL 9.231.XXX.12.ZZZ CONTROL POSITIVO STREP PNEUMO-LEGIO / STREP PNEUMO-LEGIO POSITIVE CONTROL 9.108.XXX.37.ZZZ98/79	B IVDR, 98/79	EUDAMED record Report an error
Clost. diff. incl GDH and/or toxin a and b - RT & POC	W0105090106	SIMPLE 2A-Bdiff / STICK 2A-Bdiff 9.038.XXX.YY.ZZZ98/79 SIMPLE GDH / STICK GDH 9.045.XXX.YY.ZZZ3 refs Simple GDH-Toxins 9.065.XXX.YY.ZZZ3 refs	B IVDR, 98/79	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	SIMPLE Strep pneumo-Legio / STICK Strep pneumo-Legio 9.108.XXX.YY.ZZZ98/79 Simple/Stick Campylobacter 9.230.XXX.YY.ZZZ98/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	Simple H.pyl / Stick H.pyl 9.076.XXX.YY.ZZZ98/79 VIRAPID® HELICOBACTER PYLORI/TRANSFERRIN Ag 9.231.XXX.YY.ZZZ3 refs	B IVDR, 98/79	EUDAMED record Report an error
Other virology controls - inf.imm.	W0105080804	CONTROL POSITIVO EN SECO ROTA-ADENO-NORO \|\| DRY POSITIVE CONTROL ROTA-ADENO-NORO 9.050.XXX.12.ZZZ CONTROL POSITIVO EN SECO SARS-CoV-2/Flu A+B / SARS-CoV-2/Flu A+B DRY POSITIVE CONTROL 9.242.XXX.12.ZZZ	B IVDR	EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents	W0105011607	Real Respiratory Bacterial Panel 2 (B. pertussis, B. parapertussis, B. holmesii) 5.182.XXX.YY.ZZZ2 refs	B IVDR	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	Simple AG SARS-CoV-2 / Flu A+B 9.242.XXX.YY.ZZZ3 refs	B IVDR, 98/79	EUDAMED record Report an error
Full genotyping high-risk + low-risk HPV - NA reagents	W0105041004	High + Low PapillomaStrip 3.148.XXX.YY.ZZZ98/79	– 98/79	EUDAMED record Report an error
Gram+ - gram- - fungi - multiplex NA reagents	W0105070201	Respiratory Bacterial Panel Strip 3.095.XXX.YY.ZZZ98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	Real SARS-CoV-2/Flu/RSV 5.237.XXX.88.ZZZ98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Simple Flu A+B 9.080.XX.YYY.ZZZ3 refs	B IVDR	EUDAMED record Report an error
Legionella - RT & POC	W0105090108	SIMPLE Legio pneumo / STICK Legio pneumo 9.106.XXX.YY.ZZZ98/79	– 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	Simple RSV-Flu A+B 9.081.XXX.YY.ZZZ3 refs	B IVDR	EUDAMED record Report an error
Parasitology controls - inf.imm.	W0105080805	Control positivo en seco Crypto-Giardia-Entamoeba / Crypto-Giardia-Entamoeba Dry Positive Control 9.144.011.12.000	B IVDR	EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents	W0105041003	High PapillomaStrip 3.146.XXX.YY.ZZZ98/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	Simple RSV 9.064.XXX.YY.ZZZ3 refs	B IVDR	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	STD Panel Strip 3.150.XXX.YY.ZZZ98/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Simple / Stick Strep A 9.134.XXX.YY.ZZZ3 refs	B IVDR	EUDAMED record Report an error
Strep. pneumoniae - RT & POC	W0105090109	SIMPLE Strep pneumo / STICK Strep pneumo 9.107.XXX.YY.ZZZ98/79	– 98/79	EUDAMED record Report an error
Strep. pneumoniae detection by NA reagents	W0105011105	S. PneumoStrip 3.165.XXX.YY.ZZZ98/79	– 98/79	EUDAMED record Report an error

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