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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

102261 — IVDD — General IVDD by Salofa Oy

MD Atlas
Salofa Oy

EUDAMED last updated this device on Aug 28, 2022

102261

B-FIMF16823102261KZ

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Salofa Oy
UDI-DI code: D-FIMF16823102261KZ
Reference / catalog number: 102261

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Manufacturer information

Organization name: Salofa Oy
SRN: FI-MF-000016823
Manufacturer status: Active

Market distribution

Primary placement in Hungary; available across 2 countries total.

Country	On market since	Until
HungaryPrimary placement	Oct 20, 2021	Still on market
Italy	Jan 10, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-FIMF16823102261KZ
Basic UDI-DI: B-FIMF16823102261KZ
Reference / catalog number: 102261
Issuing entity: EUDAMED

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: SARS-CoV-2 (Covid-19) Antigen Rapid Test Cassette (Saliva / Nasopharyngeal Swab) for qualitative detection of the N protein of SARS-CoV-2
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105099099VIROLOGY - RT & POC - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
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Manufacturing date
Serial number
Software identification

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.