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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

LUVAR STA — Class IIa MDR by Heyer Medical AG

MD Atlas
Heyer Medical AG

EUDAMED last updated this device on Jun 26, 2023

LUVAR STA

4251743800006UT

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Heyer Medical AG
UDI-DI code: 04251743800068
Reference / catalog number: 121200

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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
Pneumothorax - Pneumocephalus - Severe bullous lung disease - Pathologically low blood pressure - Dehydration

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Mar 5, 2023	Feb 29, 2028

Device identification

Trade name: LUVAR STA
UDI-DI code: 04251743800068
Basic UDI-DI: 4251743800006UT
Reference / catalog number: 121200
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 STA is a bilevel device for the treatment of sleep-related breathing disorders or forms of respirotory insufficiency by patients. Following software modes can be selected: CPAP, AUTOCPAP, Auto S, S, ST, T
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

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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.