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

75-75STREPA-xx — IVDD — General IVDD by Salofa Oy

MD Atlas
Salofa Oy

EUDAMED last updated this device on Aug 28, 2022

75-75STREPA-xx

B-FIMF168237575STREPAxxGG

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-FIMF168237575STREPAxxGG
Reference / catalog number: 75-75STREPA-xx

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 Sweden; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: D-FIMF168237575STREPAxxGG
Basic UDI-DI: B-FIMF168237575STREPAxxGG
Reference / catalog number: 75-75STREPA-xx
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: Rapid test for detection of Strep A (Group A Streptococcus) in throat swab specimens
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105090103STREP. A - RT & POC

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.