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 use on open or infected wounds unless appropriate wound dressings are in place. Do not use where external abdominal compression is contraindicated. Warnings and precautions: Use only on intact skin or over appropriate wound dressings. Do not apply too tightly. Ensure comfortable breathing and circulation at all times. Check the skin daily for signs of redness, irritation, or pressure marks. Adjust compression gradually according to comfort or healthcare professional advice.

• Single patient multiple use

Primary placement in Italy; available across 32 countries total.

Trade name

Calla Abdominal Compression Pro (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.

08033675198026

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.

803367519APBJK

Reference / catalog number

APB-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.