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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

SimqOSA101 — Class IIb MDR by Simq GmbH

MD Atlas
Simq GmbH

EUDAMED last updated this device on Apr 15, 2026

SimqOSA101

42623555100189

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Simq GmbH
UDI-DI code: 04262355510016
Reference / catalog number: SimqOSA101

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Manufacturer information

Organization name: Simq GmbH
SRN: DE-MF-000022283
Manufacturer status: Active

Critical warnings

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

CW011
Die Kontraindikationen sind schlafbezogene Atmungsstörungen mit Ursprung in der Perinatalperiode sowie schlafbezogene Atmungsstörungen bei Patienten und Patientinnen mit dem Obesitas-Hypoventilationssyndrom

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jun 28, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04262355510016
Basic UDI-DI: 42623555100189
Reference / catalog number: SimqOSA101
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://simq.help/osa
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z119082VARIOUS BIOIMAGING AND RADIOTHERAPY 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

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.