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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

PR02 — Class I MDD by Diametos GmbH

MD Atlas
Diametos GmbH

EUDAMED last updated this device on Apr 16, 2026

PR02

B-DEMF000009438PR02NQ

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Diametos GmbH
UDI-DI code: D-DEMF000009438PR02NQ
Reference / catalog number: PR02

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Manufacturer information

Organization name: Diametos GmbH
SRN: DE-MF-000009438
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	May 17, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-DEMF000009438PR02NQ
Basic UDI-DI: B-DEMF000009438PR02NQ
Reference / catalog number: PR02
Issuing entity: EUDAMED

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Softwareapplikation für Smartphones zur Abschätzung des Risikos einer obstruktiven Schlafapnoe im Rahmen einer Voruntersuchung (Screening).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12039092VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - 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

PR01B-DEMF000009438PR01NNOn 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.