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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

122009 — Class IIa MDR by Heyer Medical AG

MD Atlas
Heyer Medical AG

EUDAMED last updated this device on May 20, 2026

122009

4251743800006UT

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Heyer Medical AG
UDI-DI code: 04251743800280
Reference / catalog number: 122009

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Manufacturer information

Organization name: Heyer Medical AG
SRN: DE-MF-000014330
Manufacturer status: Active

Critical warnings

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

CW018
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Feb 2, 2026	Mar 1, 2028

Device identification

Trade name: not provided
UDI-DI code: 04251743800280
Basic UDI-DI: 4251743800006UT
Reference / catalog number: 122009
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: The device is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 30kg. It is intended for home and hospital use.

EMDN nomenclature code(s)

Z12030102CONTINUOUS POSITIVE PRESSURE EQUIPMENT

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

1211004251743800006UTOn the market 1220014251743800006UTOn the market 1220024251743800006UTOn the market 1220034251743800006UTOn the market 1220044251743800006UTOn 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.