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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

SERENE V 1.0.0 — Class IIa MDR by APX Intégration

MD Atlas
APX Intégration

EUDAMED last updated this device on Jun 26, 2024

SERENE V 1.0.0

3770035627SERENEV1.0.0XM

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: APX Intégration
UDI-DI code: 03770035627004
Reference / catalog number: SERENE V 1.0.0

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Manufacturer information

Organization name: APX Intégration
SRN: FR-MF-000039456
Manufacturer status: Inactive

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Jan 2, 2025	Dec 31, 2029

Device identification

Trade name: not provided
UDI-DI code: 03770035627004
Basic UDI-DI: 3770035627SERENEV1.0.0XM
Reference / catalog number: SERENE V 1.0.0
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Le logiciel de télésurveillance médicale SERENE permet d'assurer à distance le suivi standard des patients adultes souffrant de maladies chroniques. Ils sont suivis par un praticien spécialisé et il leur est prescrit d'envoyer des données sur leur état de santé. Ces données peuvent être des signes vitaux ou des questionnaires sur leur maladie chronique. Le praticien spécialiste a également prédéfini des seuils et des règles personnalisées qui seront déclenchés si les données du patient répondent à ces critères.
Additional information URL: No additional information URL provided by the manufacturer.
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

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.

Related devices

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