Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

ROZMIAR L – SW-KO-01-L — Class I MDR by Zakład Produkcji…

MD Atlas
Zakład Produkcji Pościeli "ŚWIT" Izabela Wintoniak

EUDAMED last updated this device on May 6, 2026

ROZMIAR L – SW-KO-01-L

59020960SW-KO-01RX

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: 5902096001006
Reference / catalog number: ROZMIAR L – SW-KO-01-L

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

View device family (Basic UDI)

Manufacturer information

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

Critical warnings

No critical warnings reported for this device.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	May 6, 2026	Dec 31, 2029

Device identification

Trade name: not provided
UDI-DI code: 5902096001006
Basic UDI-DI: 59020960SW-KO-01RX
Reference / catalog number: ROZMIAR L – SW-KO-01-L
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: ROZMIAR L – SW-KO-01-L
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

5902096001006

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.

T020499SURGICAL GOWNS - OTHER

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

Become a partner of MD Atlas

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.