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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

053 — Class I MDR by PURO TEHNIKA PODJETJE…

MD Atlas
PURO TEHNIKA PODJETJE ZA PREDELAVO IN TRŽENJE POLIURETANSKE PENE D.O.O.

EUDAMED last updated this device on May 28, 2026

053

3830084460539H

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PURO TEHNIKA PODJETJE ZA PREDELAVO IN TRŽENJE POLIURETANSKE PENE D.O.O.
UDI-DI code: 03831131419617
Reference / catalog number: 053

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View device family (Basic UDI)

Manufacturer information

Organization name: PURO TEHNIKA PODJETJE ZA PREDELAVO IN TRŽENJE POLIURETANSKE PENE D.O.O.
SRN: SI-MF-000031412
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Slovenia; available across 1 country total.

Country	On market since	Until
SloveniaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03831131419617
Basic UDI-DI: 3830084460539H
Reference / catalog number: 053
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)03831131419617

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

V08030102NON-ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS

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

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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.