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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

PL_TK8_B_APTEO — Class I MDR by Andrzej Bugajski…

MD Atlas
Andrzej Bugajski ,,DALPEX" Przedsiębiorstwo Produkcyjno-Handlowe

EUDAMED last updated this device on May 28, 2026

PL_TK8_B_APTEO

590198609004FT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Andrzej Bugajski ,,DALPEX" Przedsiębiorstwo Produkcyjno-Handlowe
UDI-DI code: 05908312470717
Reference / catalog number: PL_TK8_B_APTEO

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View device family (Basic UDI)

Manufacturer information

Organization name: Andrzej Bugajski ,,DALPEX" Przedsiębiorstwo Produkcyjno-Handlowe
SRN: PL-MF-000036903
Manufacturer status: Active

Related devices

PL_DLADZ_12_APTEO(DINO)590198609004FTOn the market APTEO/GAZ/0,5590198609010FNOn the market GAZA_NJ_1_APTEO590198609010FNOn the market PL_DLADZ_12_APTEO(JADZIA)590198609004FTOn the market PL_DLADZ_12_APTEO(KICIA)590198609004FTOn 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

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

CW009
EUDAMED did not publish a description for this code.
CW007
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: 05908312470717
Basic UDI-DI: 590198609004FT
Reference / catalog number: PL_TK8_B_APTEO
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: Plaster tkaninowy APTEO z opatrunkiem jest przeznaczony do opatrywania powierzchownych uszkodzeń skóry, takich jak drobne skaleczenia, otarcia czy rany. Wyrób pełni funkcję bariery mechanicznej, chroniącej ranę przed czynnikami zewnętrznymi, zanieczyszczeniami oraz otarciami. Plaster jest przeznaczony do stosowania zewnętrznego, jednorazowego użytku.
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

Encoded

(01)05908312470717

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

M04010102POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD

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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