Manufacturer

Salofa

FinlandLegal entities : Salofa Oy

Markets : Finland · Hungary · Italy · Slovenia · Sweden · United States

Approvals : United States (FDA) –

3 categories, 10 models including 9 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Virology - RT & POC - other	W0105099099	Clarity COVID-19 Antigen Rapid Test Cassette98/79 Salocor SARS-CoV-2 Antigen Rapid Test Cassette (Nasal Swab)98/79 Salocor SARS-CoV-2 Antigen Rapid Test Cassette (Nasopharyngeal Swab)98/79 Salocor SARS-CoV-2 Antigen Rapid Test Cassette (Saliva / Nasopharyngeal Swab)98/79 Salocor SARS-CoV-2 Antigen Rapid Test Cassette (Saliva)98/79 3 others Sienna COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab)98/79 Sienna COVID-19 Antigen Rapid Test Cassette (Saliva / Nasopharyngeal Swab)98/79 Sienna COVID-19 Antigen Rapid Test Cassette (Saliva)98/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Strep A test kit 75-75STREPA-xx98/79	– 98/79	EUDAMED record Report an error
Immunochemistry readers No model still on the market	W0201020201	Reader-1-S98/79 (no longer marketed)	– 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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