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 localized cooling or external compression of the eye region is contraindicated. Warnings and precautions: Use only on intact skin or over appropriate wound dressings. Do not apply too tightly. Ensure comfortable fit and circulation at all times. Check the skin daily for signs of redness, irritation, or excessive cooling. Always place the cooling packs inside the integrated textile pockets and never directly on the skin. Use cooling for short periods and remove if discomfort occurs.

• Single patient multiple use

Primary placement in Italy; available across 32 countries total.

Trade name

Calla Eye & Nose Band (Lace White)

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.

08033675199603

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.

803367519EBT8

Reference / catalog number

EBW

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

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.

• M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

• Class I medical devices in EUDAMED

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