Organization name

Titanox S.r.l.

SRN

IT-MF-000020325

Manufacturer status

Active

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

• CW999

  Use of the device is restricted to qualified healthcare personnel trained in dry heat sterilization processes. Do not use in the presence of explosive gases or vapors. Do not spill liquids onto the device. Do not open the door until the internal temperature has dropped below 30°C. Use heat-insulating gloves to avoid burns. Only load devices compatible with high temperatures (≥300°C) and completely dry. Do not load plastic or textile materials, or materials with an unknown melting point or a melting point below the specified limits. Ensure that all instruments are clean and dry before the cycle. Disconnect from the mains before cleaning or maintenance operations. Use only original spare parts. Maintain a minimum distance of 30 cm from portable RF equipment to avoid interference.

Primary placement in Italy; available across 22 countries total.

Trade name

not provided

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08059304700026

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

805930470A06PASTELKU

Reference / catalog number

A3-213-400

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Medical device designed for the disinfection and sterilization of medical devices by means of dry heat (hot air) at controlled temperature. The device enables the thermal treatment of instruments, ensuring the destruction of microorganisms through exposure to high temperatures, in accordance with the set parameters.

Additional information URL

https://www.titanox.it/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• Z12011307DRY AIR STERILISERS

• Class IIb medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.