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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

TSLO.000 — IVDR Class A IVDR by Happy Innova SL

MD Atlas
Happy Innova SL

EUDAMED last updated this device on Nov 7, 2025

TSLO.000

8437028905TSLOCU

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Happy Innova SL
UDI-DI code: 08437028905000
Reference / catalog number: TSLO.000

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Manufacturer information

Organization name: Happy Innova SL
SRN: ES-MF-000048093
Manufacturer status: Active

Critical warnings

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

CW010
Consúltense las instrucciones de uso o consúltense las instrucciones de uso electrónicas

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: 08437028905000
Basic UDI-DI: 8437028905TSLOCU
Reference / catalog number: TSLO.000
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Smart Lollipop’s intended use is for the collection, primary containment and preservation of sufficient volumes of saliva specimen for the purpose of further in vitro diagnostic examination. It is a non-automated and non-qualitative/quantitative specimen receptable for adults and children over 3 years old.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W05019002SALIVA COLLECTION DEVICES

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

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.