Organization name

Qualiteam s.r.l.

SRN

IT-MF-000026616

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• Caution

  Do not use directly on open or infected wounds. Use only on intact skin. Do not apply too tightly. Check the skin regularly and discontinue use if pain, irritation, or discomfort occurs. Do not use where external compression of the chest is contraindicated

• Single patient multiple use

Primary placement in Italy; available across 32 countries total.

Trade name

QualiBreath Infant (Small)

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.

08033675190914

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.

803367519QB00B9

Reference / catalog number

QB-INF30

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 I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Small

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

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

• Y060307THORACIC ORTHOSES

• Class I medical devices in EUDAMED

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