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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

P3421.0035.0018 — IVDR Class A IVDR by KOLASA SPÓŁKA JAWNA

MD Atlas
KOLASA SPÓŁKA JAWNA

EUDAMED last updated this device on Mar 10, 2025

P3421.0035.0018

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: 05906492942567
Reference / catalog number: P3421.0035.0018

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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

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

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: 05906492942567
Basic UDI-DI: 590649294ODHFLN
Reference / catalog number: P3421.0035.0018
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)05906492942567

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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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