DECLARATION OF CONFORMITY OP2

Product catalog summary

Declaration of Conformity Overview:

The document is a Declaration of Conformity for the product OP2, manufactured by opTricon GmbH, located in Berlin, Germany. The manufacturer declares sole responsibility for issuing the EU Declaration of Conformity.

Product Details:

Trade Name: OP2
Basic UDI-DI: 42520204OP2P4
Variants: Included as per Annex I

Intended Purpose:

The OP2 is a photometer designed for qualitative, semi-quantitative, or quantitative measurement of optical density and Europium fluorescence emission signals on test strips used in Lateral Flow Assays (LFAs) for in-vitro diagnostics. It assists in diagnosing specific disorders or conditions based on tests defined by assay reagent manufacturers. The device is used manually by professional users and is not a companion diagnostic device.

Regulatory Classification:

Class: A, according to EU Regulation 2017/746 (IVDR), Annex VIII, Rule 5 b

Compliance:

The product complies with all applicable requirements of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). No common technical specifications have been published yet.

Conformity Assessment Procedure:

Based on EU Regulation 2017/746 (IVDR), Article 17 & Annex II, Annex III

Signatory:

The document is signed by Lutz Melchior, Managing Director of opTricon GmbH, on May 14, 2025, in Berlin.

Catalog excerpts

ANHANG I ZUR KONFORMITÄTSERKLÄRUNG ANNEX I TO DECLARATION OF CONFORMITY Handelsname Produkt: Trade name product: Basic UDI-DI: DIE FOLGENDEN VARIANTEN DES O.G. PRODUKTES SIND IN DER KONFORMITÄTSERKLÄRUNG EINGESCHLOSSEN. THE FOLLOWING VARIANTS OF THE ABOVE-MENTIONED PRODUCT ARE INCLUDED IN THE DECLARATION OF CONFORMITY. Unterschrift: Signature: X Geschäftsführung / Managing Director Signiert von: Lutz Melchior Name und Funktion bei opTricon GmbH / Name and function at opTricon GmbH

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KONFORMITÄTSERKLÄRUNG / DECLARATION OF CONFORMITY Name und Adresse des Herstellers: Name and address of the Manufacturer: opTricon GmbH Schwarzschildstr.1 12489 Berlin Germany SRN des Herstellers (EUDAMED): SRN of the Manufacturer (EUDAMED): DER HERSTELLER ERKLÄRT HIERMIT, DASS ER DIE ALLEINIGE VERANTWORTUNG FÜR DIE AUSSTELLUNG DER EU-KONFORMITÄTSERKLÄRUNG TRÄGT. THE MANUFACTURER HEREBY DECLARES THAT HE IS SOLELY RESPONSIBLE FOR ISSUING THE EU DECLARATION OF CONFORMITY. DER HERSTELLER ERKLÄRT WEITERHIN, DASS DAS IN-VITRO-DIAGNOSTIKUM: THE MANUFACTURER FURTHER STATES THAT THE IN VITRO DIAGNOSTIC...

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UND ALLEN ANFORDERUNGEN DER VERORDNUNG ÜBER IN-VITRO-DIAGNOSTIKA (EU) 2017/746 (IVDR) ENTSPRECHEN, DIE ANWENDBAR SIND. AND COMPLY WITH ALL REQUIREMENTS OF THE IN VITRO DIAGNOSTIC MEDICAL DEVICES REGULATION (EU) 2017/746 (IVDR) THAT APPLY. Angewandte Gemeinsame Technische Spezifikationen: Applied common technical specifications: N/A (bisher keine veröffentlicht / none published yet) Konformitätsbewertungsverfahren: Conformity assessment procedure: (EU) 2017/746 (IVDR); Art. 17 & Annex II, Annex III Konformitätsbewertungsstelle (falls beigezogen): Notified Body (if consulted): Unterschrift: Signature:...

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