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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

OT-02-422OH — Class I MDR by Infimed Spółka z…

MD Atlas
Infimed Spółka z ograniczona odpowiedzialnością

EUDAMED last updated this device on Sep 11, 2025

OT-02-422OH

5904384698OT02VIVAXW4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Infimed Spółka z ograniczona odpowiedzialnością
UDI-DI code: 05904384698349
Reference / catalog number: OT-02-422OH

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View device family (Basic UDI)

Manufacturer information

Organization name: Infimed Spółka z ograniczona odpowiedzialnością
SRN: PL-MF-000015633
Manufacturer status: Active

Related devices

IS-015904384698IS01OPERAMEOn the market OL-01/015904384698OLNEXUS9LOn the market OL-01/025904384698OLNEXUS9LOn the market OL-01C5904384698OLNEXUS9LOn the market OL-01CAM/01/S5904384698OLNEXUS9LOn 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

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

CW010
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: 05904384698349
Basic UDI-DI: 5904384698OT02VIVAXW4
Reference / catalog number: OT-02-422OH
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on 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

EMDN nomenclature code(s)

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

Z12011202OPERATING TABLES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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