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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

T5R21020E16R0000 — Class I MDR by PRZEDSIĘBIORSTWO…

MD Atlas
PRZEDSIĘBIORSTWO INNOWACYJNO-HANDLOWE "VARIA" Sp. z o.o.

EUDAMED last updated this device on May 27, 2026

T5R21020E16R0000

590307622TPAPEREKGND

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PRZEDSIĘBIORSTWO INNOWACYJNO-HANDLOWE "VARIA" Sp. z o.o.
UDI-DI code: 05903076220110
Reference / catalog number: T5R21020E16R0000

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View device family (Basic UDI)

Manufacturer information

Organization name: PRZEDSIĘBIORSTWO INNOWACYJNO-HANDLOWE "VARIA" Sp. z o.o.
SRN: PL-MF-000051067
Manufacturer status: Active

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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

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Jan 1, 2000	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05903076220110
Basic UDI-DI: 590307622TPAPEREKGND
Reference / catalog number: T5R21020E16R0000
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: Papier EKG Ascard GOLD, BTL 08LC/ 08LT / 210x20 Producent: Varia Sp. z o. o. Kod produktu: T5R21020E16R0000 Rozmiar: rolka 210x20 Zastosowanie: BTL 08 LC/ BTL 08 LT Ilość w opakowaniu: 5 rolek Opis produktu Termiczny papier rejestracyjny do aparatów EKG firmy BTL, modele 08-LC / 08-LT. Wymiary papieru to 210x20. Rolka o długości 20 m, kratka.
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)05903076220110

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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.

Z1302DIAGNOSTIC REGISTRATION PAPERS

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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