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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

mebix_1_4 — Class I MDR by Vision2B GmbH

MD Atlas
Vision2B GmbH

EUDAMED last updated this device on Feb 22, 2022

mebix_1_4

426235227mebixVU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Vision2B GmbH
UDI-DI code: 04262352270005
Reference / catalog number: mebix_1_4

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Manufacturer information

Organization name: Vision2B GmbH
SRN: DE-MF-000019021
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
Die “Erinnerungsfunktion für Medikamente” ist ein zusätzlicher Service von mebix und stellt kein Leistungsversprechen dar. Es besteht grundsätzlich ein Rest-Risiko, dass diese Erinnerungsfunktion (Push-Service) ausfallen kann. Der Hersteller haftet nicht für etwaig auftretende Schäden des Nutzers

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: 04262352270005
Basic UDI-DI: 426235227mebixVU
Reference / catalog number: mebix_1_4
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 Mebix App unterstützt diabetes- bzw. herzerkrankte Patienten/-innen bei der Umsetzung Ihrer vom Arzt verordneten Therapie und im Selbstmanagement ihrer chronischen Krankheit.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040292GENERAL MEDICINE THERAPEUTIC TREATMENT 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.