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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

2100015644 — Class I MDR by NEVEON Austria GmbH

MD Atlas
NEVEON Austria GmbH

EUDAMED last updated this device on Dec 30, 2023

2100015644

9006399HygienicCovers8P

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NEVEON Austria GmbH
UDI-DI code: 09006399000400
Reference / catalog number: 2100015644

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Manufacturer information

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

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Market distribution

Primary placement in Austria; available across 1 country total.

Placed on the market in Austria; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 09006399000400
Basic UDI-DI: 9006399HygienicCovers8P
Reference / catalog number: 2100015644
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 hygienic cover can be used for all mattresses and features very good mechanical properties and good breathability. It can be used in hospitals, rehabilitation centers, retirement and nursing homes, 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)

V0880MEDICAL SUPPORT EQUIPMENT - 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

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.