Calla Ear Band

Organization name

Qualiteam s.r.l.

SRN

IT-MF-000026616

Manufacturer status

Active

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

• CW011

  Contraindications: Do not use on open or infected wounds unless appropriate wound dressings are in place. Do not use where external compression is contraindicated. Warnings and precautions: Use only on intact skin or over appropriate wound dressings. Do not apply too tightly. Ensure comfortable circulation at all times. Check the skin daily for signs of redness, irritation, or pressure marks. 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.
• CW262

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 32 countries total.

Trade name

not provided

UDI-DI code

08033675199641

Basic UDI-DI

803367519EAT6

Reference / catalog number

Calla Ear Band

Issuing entity

GS1

Risk category

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