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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

A009 — Class I MDR by ALMA PHIL GmbH

MD Atlas
ALMA PHIL GmbH

EUDAMED last updated this device on Sep 24, 2024

A009

426243364A0009PT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ALMA PHIL GmbH
UDI-DI code: 04262433640093
Reference / catalog number: A009

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Manufacturer information

Organization name: ALMA PHIL GmbH
SRN: DE-MF-000008685
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: 04262433640093
Basic UDI-DI: 426243364A0009PT
Reference / catalog number: A009
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: Bei der digitalen Gesundheitshelferin ADELE psychische Beschwer- den und Krankheitsbilder handelt es sich um eine digitale Lösung, die dem Anwender durch die Erfassung und Deutung seines psychi- schen Befindens und seines körperlichen Zustandes sowie durch die Einstellung von Erinnerungen (z.B. für die Medikamenteneinnahme), die Empfehlung individualisierter Übungen sowie die Ausgabe von Hinweisen einen besseren Umgang mit seinem psychischen Befin- den und seines körperlichen Zustandes bzw. etwaigen Beeinträchti- gungen ermöglicht.
Additional information URL: https://www.almaphil.de/
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

Related devices

A0005426243364A0005PKOn the market

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.