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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

94347 — Class I MDR by PURTEX s.r.o.

MD Atlas
PURTEX s.r.o.

EUDAMED last updated this device on May 19, 2026

94347

85951574Elegans3X

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PURTEX s.r.o.
UDI-DI code: 85928373969896
Reference / catalog number: 94347

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Manufacturer information

Organization name: PURTEX s.r.o.
SRN: CZ-MF-000053672
Manufacturer status: Active

Related devices

20008910085951574ANDEMACLASICR6On the market 9644385951574VIA7WOn the market

Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement	May 19, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 85928373969896
Basic UDI-DI: 85951574Elegans3X
Reference / catalog number: 94347
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: Pasivní antidekubitní zdravotnická matrace určená pro podporu prevence dekubitů a zvýšení komfortu pacienta při dlouhodobém ležení. Prostředek je neaktivní, neinvazivní, bez elektrického pohonu a je určen pro použití ve zdravotnických a pečovatelských zařízeních nebo v domácí péči.
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
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.