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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

29 — Class IIa MDR by Helmedica AG

MD Atlas
Helmedica AG

EUDAMED last updated this device on Jul 26, 2024

29

7649990987BenecuraDJ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Helmedica AG
UDI-DI code: 07649990987125
Reference / catalog number: 29

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Manufacturer information

Organization name: Helmedica AG
SRN: CH-MF-000040546
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 07649990987125
Basic UDI-DI: 7649990987BenecuraDJ
Reference / catalog number: 29
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: Die Applikation (APP) BENECURA ist eine mobile Anwendung mit verschiedenen Funktionen (Modulen) rund um das Thema Gesundheit und persönliche Krankengeschichte. Registrierte und namentlich eindeutig identifizierte Benutzer, können in einem Modul namens SymptomCheck eine Handlungsempfehlung oder Behandlungsempfehlung für nächste Schritte (z.B. Weiterweisung zu einem Arzt oder Durchführung bestimmter Massnahmen mit dem Zweck der Symptomlinderung oder Heilung) zu medizinischen Belangen erhalten.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040182GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES

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

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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.