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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

P3421.0035.0020 — IVDR Class A IVDR by KOLASA SPÓŁKA JAWNA

MD Atlas
KOLASA SPÓŁKA JAWNA

EUDAMED last updated this device on Mar 10, 2025

P3421.0035.0020

590649294ODHFLN

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: KOLASA SPÓŁKA JAWNA
UDI-DI code: 05906492942574
Reference / catalog number: P3421.0035.0020

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View device family (Basic UDI)

Manufacturer information

Organization name: KOLASA SPÓŁKA JAWNA
SRN: PL-MF-000044993
Manufacturer status: Active

Related devices

3421.21590649294ODHFLNOn the market 1077.5590649294ODBAKSOn the market 1052.3590649294ODBAKSOn the market 2012.5590649294ODBKLEOn the market 2012.2590649294ODBKLEOn the market

Critical warnings

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

CW265
EUDAMED did not publish a description for this code.
CW042
EUDAMED did not publish a description for this code.
CW044
EUDAMED did not publish a description for this code.

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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: 05906492942574
Basic UDI-DI: 590649294ODHFLN
Reference / catalog number: P3421.0035.0020
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
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)05906492942574

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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.

W01030705FIXING REAGENTS (HISTOLOGY/CYTOLOGY)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.