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

114253 — IVDD — General IVDD by Reagena Oy

MD Atlas
Reagena Oy

EUDAMED last updated this device on Dec 18, 2023

114253

B-114253MA

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Reagena Oy
UDI-DI code: D-114253MA
Reference / catalog number: 114253

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: Reagena Oy
SRN: FI-MF-000002804
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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-114253MA
Basic UDI-DI: B-114253MA
Reference / catalog number: 114253
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: ReaScan CXCL13 is an immunochromatographic rapid test for semiquantitative determination of chemokine CXCL13 in human cerebrospinal fluid (CSF). The test result is read from the test cassette with the ReaScan+ reader (105100, Reagena Oy, Finland).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102160199SPECIFIC PROTEINS 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

18007264300744510007298On the market Ethanol fixative 50 % V/V, incl. eosin (120 x 10 ml)643007445102354SC77On the market Ethanol fixative 50 % V/V, incl. eosin (120 x 25 ml)643007445102354SC77On the market Ethanol fixative 50 % V/V, incl. eosin (84 x 50 ml)643007445102354SC77On the market 182256643007445102256A2On 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.