Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

COV-061-S — IVDD — General IVDD by Salofa Oy

MD Atlas
Salofa Oy

EUDAMED last updated this device on Aug 28, 2022

COV-061-S

B-FIMF16823COV061STD

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-FIMF16823COV061STD
Reference / catalog number: COV-061-S

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Market distribution

Primary placement in Finland; available across 1 country total.

Placed on the market in Finland; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: D-FIMF16823COV061STD
Basic UDI-DI: B-FIMF16823COV061STD
Reference / catalog number: COV-061-S
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) 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
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

CT Filling Set 120 cmB-FIMF16823CTFS120DRV4VOn the market CT Patient Line 120 cm (300 psi)B-FIMF16823CTPL120RVH8SOn the market CT Patient Line 20 cm (300 psi)B-FIMF16823CTPL020RVH8DOn the market CT Patient Line 40 cm (300 psi)B-FIMF16823CTPL040RVH93On the market CT Patient Line 40 cm (300 psi), 2 valvesB-FIMF16823CTPL040RV2H78On the market

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.