Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Microreader II — IVDR Class A IVDR by opTricon GmbH

MD Atlas
opTricon GmbH

EUDAMED last updated this device on Jul 2, 2025

Microreader II

42520204MR2NY

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: 04252020400124
Reference / catalog number: MRII-968-01

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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 France; available across 1 country total.

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

Device identification

Trade name: Microreader II
UDI-DI code: 04252020400124
Basic UDI-DI: 42520204MR2NY
Reference / catalog number: MRII-968-01
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: Microreader II; Distributed by: BIOSYNEX SA; Ref.-No: Microreader II / MR2
Additional information URL: https://www.optricon.de/en/IFU-Microreader-II
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
Serial number
Software identification

Related devices

CUBE-75542520204CUBEDQOn the market Cube Reader42520204CUBEDQOn the market Cube Reader42520204CUBEDQOn the market CUBE-80242520204CUBEDQOn the market Cube Reader42520204CUBEDQOn 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.