Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ 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

Gauze swab, sterile — Class I MDR by STERIWUND spol. s r.o.

MD Atlas
STERIWUND spol. s r.o.

EUDAMED last updated this device on Feb 23, 2026

Gauze swab, sterile

859515411KOMPRES36

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: STERIWUND spol. s r.o.
UDI-DI code: 08595154101946
Reference / catalog number: 0164

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?

Manufacturer information

Organization name: STERIWUND spol. s r.o.
SRN: CZ-MF-000036963
Manufacturer status: Active

Related devices

Cellulose wadding tampons devided85951541045VSOn the market Cellulose wadding tampons devided85951541045VSOn the market Cellulose wadding tampons devided85951541045VSOn the market Cohesive bandage85951541044VQOn the market Cohesive bandage85951541044VQOn the market

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement		Still on market

Device identification

Trade name: Gauze swab, sterile
UDI-DI code: 08595154101946
Basic UDI-DI: 859515411KOMPRES36
Reference / catalog number: 0164
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: 4
Additional product description: 8 vrstvý
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 7,5
7,5

EMDN nomenclature code(s)

M0201050101COTTON GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE

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

Certificate health across this manufacturer's portfolio.

26 0022 QR/NBIssued
Quality management systemNotified body: 1023Expiry: Feb 11, 2031