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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

ROZMIAR XL – SW-U-01-XL — Class I MDR by Zakład Produkcji…

MD Atlas
Zakład Produkcji Pościeli "ŚWIT" Izabela Wintoniak

EUDAMED last updated this device on Apr 28, 2026

ROZMIAR XL – SW-U-01-XL

59020960SW-U-01HZ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Zakład Produkcji Pościeli "ŚWIT" Izabela Wintoniak
UDI-DI code: 5902096001099
Reference / catalog number: ROZMIAR XL – SW-U-01-XL

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Manufacturer information

Organization name: Zakład Produkcji Pościeli "ŚWIT" Izabela Wintoniak
SRN: PL-MF-000043811
Manufacturer status: Active

Related devices

100/160 - SW-POSZ-100/160 + zakładka 30 cm59020960SW-POSZTROn the market 100/160 - SW-PR-100/16059020960SW-PRNROn the market 150/210- SW-PR-150/21059020960SW-PRNROn the market 150/220 – SW-PR-150/22059020960SW-PRNROn the market 160/210 - SW-PR-160/21059020960SW-PRNROn the market

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 Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Apr 28, 2026	Dec 31, 2029

Device identification

Trade name: not provided
UDI-DI code: 5902096001099
Basic UDI-DI: 59020960SW-U-01HZ
Reference / catalog number: ROZMIAR XL – SW-U-01-XL
Issuing entity: HIBCC

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: Odzież chirurgiczna niejałowa – ubranie chirurgiczne DAMSKIE/MĘSKIEROZMIAR XL – SW-U-01-XL
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

5902096001099

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

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

T020401STANDARD SURGICAL GOWNS

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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