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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

121100 — Class IIa MDR by Heyer Medical AG

MD Atlas
Heyer Medical AG

EUDAMED last updated this device on Jun 14, 2023

121100

4251743800006UT

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Heyer Medical AG
UDI-DI code: 04251743800082
Reference / catalog number: 121100

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Manufacturer information

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

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Critical warnings

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

CW018
The device must not be used for patients with pneumothorax or pneumocephalus or pathological hypotension or severe bullous lung disease

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Mar 6, 2023	Mar 1, 2028

Device identification

Trade name: not provided
UDI-DI code: 04251743800082
Basic UDI-DI: 4251743800006UT
Reference / catalog number: 121100
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: The device was developed according to the ISO 80601-2-70 as homecare sleep apnea device. LUVAR A is a monolevel device for the treatment of sleep-related breathing disorders by patients. Following software modes can be selected: CPAP; AUTOCPAP
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

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

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.