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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

3000081077 — Class I MDR by NEVEON Austria GmbH

MD Atlas
NEVEON Austria GmbH

EUDAMED last updated this device on Sep 6, 2023

3000081077

9006399DekuStarXDL8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NEVEON Austria GmbH
UDI-DI code: 09006399000660
Reference / catalog number: 3000081077

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Manufacturer information

Organization name: NEVEON Austria GmbH
SRN: AT-MF-000003497
Manufacturer status: Active

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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.

Market distribution

Primary placement in Austria; available across 2 countries total.

Country	On market since	Until
AustriaPrimary placement	Mar 1, 2021	Still on market
Germany	Mar 1, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: 09006399000660
Basic UDI-DI: 9006399DekuStarXDL8
Reference / catalog number: 3000081077
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: This one-sided anti-decubitus mattress is ideal for patients at risk of bedsores as well as for allergy sufferers. It can be used in hospitals, retirement and nursing homes, rehabilitation centers and home care situations.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V080702NON ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES

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
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Software identification