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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

011997 — IVDR Class A IVDR by ŽIKPLAST Žitnik Anja s.p.

MD Atlas
ŽIKPLAST Žitnik Anja s.p.

EUDAMED last updated this device on May 23, 2026

011997

383008604SPECONWISPOONP2

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: ŽIKPLAST Žitnik Anja s.p.
UDI-DI code: 03830086040013
Reference / catalog number: 011997

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View device family (Basic UDI)

Manufacturer information

Organization name: ŽIKPLAST Žitnik Anja s.p.
SRN: SI-MF-000054229
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.

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: 03830086040013
Basic UDI-DI: 383008604SPECONWISPOONP2
Reference / catalog number: 011997
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 100
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)03830086040013

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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.

W050180SAMPLES COLLECTION DEVICES - OTHER ACCESSORIES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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