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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

4260676710344 — Class IIa MDR by be-on-market GmbH

MD Atlas
be-on-market GmbH

EUDAMED last updated this device on Dec 2, 2024

4260676710344

426067671_Reconwellone_TF

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: be-on-market GmbH
UDI-DI code: 04260676710344
Reference / catalog number: 4260676710344

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Manufacturer information

Organization name: be-on-market GmbH
SRN: DE-MF-000006151
Manufacturer status: Active

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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.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Dec 2, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260676710344
Basic UDI-DI: 426067671_Reconwellone_TF
Reference / catalog number: 4260676710344
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: ReconWell is a medical device software. ReconWell consisting of ReconWell App and ReconWell Dashboard supports individuals with mental health disorders during and after their medical or psychotherapeutic treatment through interactive modules, symptom tracking and tailored reminders. The ReconWell Dashboard supports healthcare professionals with information about the patient's symptoms and progress in therapy
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z129092VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - 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

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