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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

SPL-0002 — IVDD — General IVDD by SPOTLAB SL

MD Atlas
SPOTLAB SL

EUDAMED last updated this device on Apr 3, 2025

SPL-0002

B-ESMF000044194TRS4W

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: SPOTLAB SL
UDI-DI code: D-ESMF000044194TRS4W
Reference / catalog number: SPL-0002

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Manufacturer information

Organization name: SPOTLAB SL
SRN: ES-MF-000044194
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: D-ESMF000044194TRS4W
Basic UDI-DI: B-ESMF000044194TRS4W
Reference / catalog number: SPL-0002
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: TiraSpot is a software-based in vitro diagnostic medical device consisting of a smartphone application and cloud platform designed to capture, interpret, store, and enable remote visualization of rapid diagnostic test (RDT) results for infectious diseases.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02079092VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
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Software identification

Related devices

SPL-0001B-ESMF000044194ADSYJOn 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.