MG455BA

Organization name

ZAMAR MEDICAL d.o.o.

SRN

HR-MF-000023546

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  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

03858894530427

Basic UDI-DI

B-03858894530427

Reference / catalog number

MG455BA

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Z-ONE is a portable active therapeutic medical device intended for the treatment of the musculoskeletal system through controlled cryotherapy. The device circulates cooled liquid in a closed-loop system through dedicated thermal wraps designed for different anatomical areas, providing continuous and stable temperature management during treatment. The system is intended to support post-operative recovery, rehabilitation, pain management, edema reduction, and recovery following musculoskeletal injuries or physical activity. The device may be used in hospitals, clinics, physiotherapy centers, sports medicine environments, and professional home-care settings under the supervision of healthcare professionals. Z-ONE operates with a closed clean liquid circuit without direct contact between the patient and the circulating fluid, minimizing contamination risks and reducing routine maintenance requirements.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

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

This device is not currently linked to any other device.