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

A58422 — IVDD — General IVDD by GeneProof a.s.

MD Atlas
GeneProof a.s.

EUDAMED last updated this device on May 21, 2026

A58422

B-08595696304294

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: GeneProof a.s.
UDI-DI code: 08595696304294
Reference / catalog number: A58422

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: GeneProof a.s.
SRN: CZ-MF-000002370
Manufacturer status: Active

Related devices

CGRT6/96859569630077R4On the market ADV/ISEX/025B-08594161952756On the market ADV/ISEX/100B-08594161952770On the market ASP/ISEX/100B-08594161952923On the market ASP/ISEX/025B-08594161952909On the market

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 Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement		Still on market
Netherlands		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08595696304294
Basic UDI-DI: B-08595696304294
Reference / catalog number: A58422
Issuing entity: GS1

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: Kit is intended to detect polymorphism of the F13A1 gene encoding the subunit A of FXIII factor by the real-time Polymerase Chain Reaction (PCR) method. The clinical specimen used for the detection is whole blood. The intended users are professional personnel of clinical laboratories.
Additional information URL: https://www.geneproof.com/products
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0106010199MONOGENETIC DISORDERS TESTS - 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

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.