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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

H'ability Home — Class I MDR by H'ABILITY

MD Atlas
H'ABILITY

EUDAMED last updated this device on Jun 11, 2025

H'ability Home

3770028035habilityLN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: H'ABILITY
UDI-DI code: 03770028035007
Reference / catalog number: H'ability Home

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Manufacturer information

Organization name: H'ABILITY
SRN: FR-MF-000027375
Manufacturer status: Active

Critical warnings

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

CW011
Le dispositif ne doit pas être utilisé sur des patients qui : - sont âgés de moins de 18 ans - sont sujets à des troubles d’épilepsie - présentent des troubles visuels ou cognitifs ne permettant pas l’utilisation du dispositif - possèdent un implant cochléaire - possèdent un pacemaker

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: H'ability Home
UDI-DI code: 03770028035007
Basic UDI-DI: 3770028035habilityLN
Reference / catalog number: H'ability Home
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: H'ability Home est une solution de réalité virtuelle, un outil pour les professionnels de santé (rééducation & médico-social), leur permettant de proposer une rééducation / mise en mouvement plus ludique de leurs patients à la fois en structure mais aussi au domicile.
Additional information URL: https://hability.fr/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

H'ability3770028035habilityLNOn 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.