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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

IDA — IVDD — General IVDD by iSTOC Oy

MD Atlas
iSTOC Oy

EUDAMED last updated this device on Feb 16, 2023

IDA

B-GMDN440824D

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: iSTOC Oy
UDI-DI code: D-GMDN440824D
Reference / catalog number: 012016

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Manufacturer information

Organization name: iSTOC Oy
SRN: FI-MF-000033355
Manufacturer status: Inactive

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: IDA
UDI-DI code: D-GMDN440824D
Basic UDI-DI: B-GMDN440824D
Reference / catalog number: 012016
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: The system consists of a generic software reader in mobile device and a software information system. The software reader which utilizes mobile device camera interprets the result of a lateral flow test (LFT) result based on manufacturer instructions, for example, from infectious disease tests, and the test result is then ultimately confirmed by the user. The image and the test result are transferred to a cloud based software information system. IDA solution converts the diagnostic data into immediate and actionable health information.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201020192AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification

Related devices

This device is not currently linked to any other device.

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.