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

PL_TK8_C_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_C_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: 05901986090021
Reference / catalog number: PL_TK8_C_APTEO

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

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.

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		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05901986090021
Basic UDI-DI: 590198609004FT
Reference / catalog number: PL_TK8_C_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)05901986090021

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

UDI-PI DataMatrix

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

Sign in to generate the UDI-PI DataMatrix

Create a free account, then generate the compliant UDI-PI carrier for this device.

Email

Password

No account yet?

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

Become a partner of MD Atlas

Related devices

PL_TK8_B_APTEO590198609004FTOn the market 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

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.