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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

PRESAGE CARE — Class I MDD by PRESAGE

MD Atlas
PRESAGE

EUDAMED last updated this device on Mar 29, 2024

PRESAGE CARE

B-37700214140076

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PRESAGE
UDI-DI code: 37700214140076
Reference / catalog number: PRESAGE-CARE V1.x.x

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Manufacturer information

Organization name: PRESAGE
SRN: FR-MF-000002466
Manufacturer status: Active

Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement	Feb 28, 2020	Nov 30, 2028
Belgium	Apr 3, 2023	Nov 30, 2028

Device identification

Trade name: PRESAGE CARE
UDI-DI code: 37700214140076
Basic UDI-DI: B-37700214140076
Reference / catalog number: PRESAGE-CARE V1.x.x
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: PRESAGE CARE est un dispositif médical numérique de télésurveillance médicale des personnes âgées en risque de perte d'autonomie.
Additional information URL: https://presage.care/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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.