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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

2SMARTFinder Color Compensation — IVDR Class A IVDR

MD Atlas
PathoFinder B.V.

EUDAMED last updated this device on Jun 13, 2023

2SMARTFinder Color Compensation

87193271161PFCC-2SKV

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: PathoFinder B.V.
UDI-DI code: 08719327116173
Reference / catalog number: PFCC-2S

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View device family (Basic UDI)

Manufacturer information

Organization name: PathoFinder B.V.
SRN: NL-MF-000002704
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

1 warning recorded — scroll inside the panel to see all entries.

CW010
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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	Apr 20, 2023	Still on market

Device identification

Trade name: 2SMARTFinder Color Compensation
UDI-DI code: 08719327116173
Basic UDI-DI: 87193271161PFCC-2SKV
Reference / catalog number: PFCC-2S
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: The 2SmartFinder® Color Compensation Kit is an accessory product for the IVDs in the 2SmartFinder® product line. It contains reagents to generate a Color Compensation file on LightCycler® 480 II/ cobas® z480 (Roche) and reagents to create custom Dye files to enable use of said IVDs on a QuantStudio™ 5 instrument (ThermoFisher).
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

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0101050199MULTICOMPONENT CONTROLS (CC) - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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