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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

4260676710207 — Class I MDR by be-on-market GmbH

MD Atlas
be-on-market GmbH

EUDAMED last updated this device on May 30, 2023

4260676710207

426067671_GHT_HYPA6T

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: be-on-market GmbH
UDI-DI code: 04260676710207
Reference / catalog number: 4260676710207

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Manufacturer information

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

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 04260676710207
Basic UDI-DI: 426067671_GHT_HYPA6T
Reference / catalog number: 4260676710207
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: Die digitale Gesundheitsanwendung HYPA unterstützt Patient:innen mit leichtem bis mittlerem Bluthochdruck(Hypertonie Grad I + II) bei der Lebensstilumstellung zur gezielten Blutdruckreduktion. Die Blutdruckreduktion ist dabei Folge einer Verhaltensänderung der Patient:innen in Bezug auf die eigene Ernährung, Bewegung und weitere gesundheitsrelevante Gewohnheiten. Ziel der Verhaltensänderung ist eine quantitative und qualitative Veränderung der Nahrungsaufnahme und eine Erhöhung des Bewegungsoutputs, welche im Ergebnis zu einer anhaltenden regulierten Blutdrucksituation führen soll. Die Verhaltensänderung wird dabei durch die Anwendung verschiedener verhaltenswissenschaftlicher Methoden erzielt.
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

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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.