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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

T5Z112100150R001 — Class I MDR by PRZEDSIĘBIORSTWO…

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

EUDAMED last updated this device on May 28, 2026

T5Z112100150R001

590307622TPAPERKTGQ6

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: 05903076221131
Reference / catalog number: T5Z112100150R001

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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	Feb 5, 2020	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05903076221131
Basic UDI-DI: 590307622TPAPERKTGQ6
Reference / catalog number: T5Z112100150R001
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 KTG Sunray SRF 618B / SRF 628B / SRF 638B, BIOCARE FM-801 112x100x150 Producent: Varia Sp. z o. o. Kod produktu: T5Z112100150R001 Rozmiar: składanka 112x100x150 Zastosowanie: do aparatu KTG Sunray SRF618B / SRF628B / SRF638B, BIOCARE FM801 Ilość w opakowaniu: 1 bloczek Papier termiczny do aparatu KTG Sunray SRF-618B / SRF-628B / SRF-638B, BIOCARE FM 801 o wymiarach 112x100x150. Składanka 150 stron w bloczku. Papier nadrukowany w skali FHR 60 - 210 bpm.
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)05903076221131

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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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