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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

LORIO — Class I MDR by HAPPLYZ Medical

MD Atlas
HAPPLYZ Medical

EUDAMED last updated this device on Nov 19, 2022

LORIO

3770027009HAPPUADFQM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: HAPPLYZ Medical
UDI-DI code: 03770027009009
Reference / catalog number: HAPP_UADF_01-00

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Manufacturer information

Organization name: HAPPLYZ Medical
SRN: FR-MF-000016072
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: LORIO
UDI-DI code: 03770027009009
Basic UDI-DI: 3770027009HAPPUADFQM
Reference / catalog number: HAPP_UADF_01-00
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: LORIO is a digital solution that combines a connected flute with video games on application mobile and intended for respiratory insufficiency to allow them to carry out exercises respiratory rehabilitation in a fun way.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

R900902INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

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.