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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

0398 — 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

0398

859515408NAVLEKRC

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: STERIWUND spol. s r.o.
UDI-DI code: 08595154109676
Reference / catalog number: 0398

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Manufacturer information

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

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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: not provided
UDI-DI code: 08595154109676
Basic UDI-DI: 859515408NAVLEKRC
Reference / catalog number: 0398
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: 110 MU10
70 MU10

EMDN nomenclature code(s)

T030102COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS

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