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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

e-fitback — Class I MDD by NOUVEAL

MD Atlas
NOUVEAL

EUDAMED last updated this device on Dec 6, 2021

e-fitback

B-03770022141001

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: NOUVEAL
UDI-DI code: 03770022141001
Reference / catalog number: EFIT

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Manufacturer information

Organization name: NOUVEAL
SRN: FR-MF-000003650
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: e-fitback
UDI-DI code: 03770022141001
Basic UDI-DI: B-03770022141001
Reference / catalog number: EFIT
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: Solution de télésuivi ou de télésurveillance adaptée à toutes les prises en charge, toutes les aires thérapeutiques. Son objectif est de sécuriser et faciliter la prise en charge de tous les patients en structurant les chemins cliniques.
Additional information URL: https://www.nouveal.com/references/e-fitback
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

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.