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

  Contraindications: Do not place directly over open or infected wounds. Warnings and precautions: Ensure the belt is positioned correctly so the driveline exits freely between the two bands without pressure or obstruction. Do not apply excessive compression that may cause discomfort or affect the driveline. Check the skin regularly for signs of redness or irritation. Use caution in patients with reduced skin sensation or impaired circulation. Ensure the device does not interfere with other medical devices or driveline systems.

• Single patient multiple use

Primary placement in Italy; available across 32 countries total.

Trade name

DUO LVAD Driveline Support Binder (S)

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.

08033675193465

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.

803367519DUOLB

Reference / catalog number

DUO-S

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.

• Y060499ABDOMINAL ORTHOSES - OTHER

• Class I medical devices in EUDAMED

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