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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

OP2 — IVDR Class A IVDR by opTricon GmbH

MD Atlas
opTricon GmbH

EUDAMED last updated this device on May 23, 2025

OP2

42520204OP2P4

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: opTricon GmbH
UDI-DI code: 04252020400148
Reference / catalog number: OP2-1294-225

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Manufacturer information

Organization name: opTricon GmbH
SRN: DE-MF-000024656
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: OP2
UDI-DI code: 04252020400148
Basic UDI-DI: 42520204OP2P4
Reference / catalog number: OP2-1294-225
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: OP2; Distributed by: concile GmbH; Ref.: "concile® DUO"
Additional information URL: https://www.optricon.de/en/IFU-OP2
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201020201IMMUNOCHEMISTRY READERS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification

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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.