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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

1.06.016 — Class I MDR by "FLESZ" SPÓŁKA Z…

MD Atlas
"FLESZ" SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

EUDAMED last updated this device on Jul 25, 2024

1.06.016

5901323945podklady4X

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: "FLESZ" SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
UDI-DI code: 05901323947315
Reference / catalog number: 1.06.016

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View device family (Basic UDI)

Manufacturer information

Organization name: "FLESZ" SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
SRN: PL-MF-000042266
Manufacturer status: Active

Related devices

1.06.0055901323945podklady4XOn the market 1.06.0105901323945podklady4XOn the market 1.06.0085901323945podklady4XOn the market 1.06.0045901323945podklady4XOn the market 1.06.0735901323945podklady4XOn 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

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

Placed on the market in Poland; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 05901323947315
Basic UDI-DI: 5901323945podklady4X
Reference / catalog number: 1.06.016
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: 6
Additional product description: Podkład medyczny celulozowy 2w Flesz 50cm/80mb 6 szt
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 50 MU10
80 MU36

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05901323947315

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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.

T04010203ABSORBENT ANTIMICROBIAL UNDERPADS

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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