DILATLAX® - Balloon Dilation System

Organization name

BenCorpp Srl

SRN

IT-MF-000023046

Manufacturer status

Active

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

• CW001

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW011

  Airway Balloon dilation catheters should be used in hospital by or under supervision of physicians thoroughly trained in airway balloon dilatation specialized in otorhinolaryngology, pneumology or surgery. A thorough understanding of the technical principles, clinical application, and risk associated with balloon dilatation of the airway tree is necessary before using this device.

Primary placement in Italy; available across 32 countries total.

Trade name

DILATLAX® - Balloon Dilation System

UDI-DI code

08056209010069

Basic UDI-DI

805620901tlaSX

Reference / catalog number

TLA 014-40-550

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.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Q030399INSTRUMENTS FOR ENT SURGERY, SINGLE-USE - OTHER

Certificate health across this manufacturer's portfolio.