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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

11-SEI-EX01-2PL — Class I MDR by TORUŃSKIE ZAKŁADY…

MD Atlas
TORUŃSKIE ZAKŁADY MATERIAŁÓW OPATRUNKOWYCH SPÓŁKA AKCYJNA

EUDAMED last updated this device on Feb 12, 2026

11-SEI-EX01-2PL

5900516AARXXXXWS

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: TORUŃSKIE ZAKŁADY MATERIAŁÓW OPATRUNKOWYCH SPÓŁKA AKCYJNA
UDI-DI code: 05900516802646
Reference / catalog number: 11-SEI-EX01-2PL

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View device family (Basic UDI)

Manufacturer information

Organization name: TORUŃSKIE ZAKŁADY MATERIAŁÓW OPATRUNKOWYCH SPÓŁKA AKCYJNA
SRN: PL-MF-000002200
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

TNP/MDR/0035/4722/2025Amended
Quality management systemNotified body: 2274Expiry: Jun 23, 2030
TNP/MDR/0036/4722/2025Issued
Technical documentationNotified body: 2274Expiry: Jun 23, 2030

Critical warnings

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

CW022
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05900516802646
Basic UDI-DI: 5900516AARXXXXWS
Reference / catalog number: 11-SEI-EX01-2PL
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: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

T04010102SHAPED INCONTINENCE NAPPIES

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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