10040001

Organization name

Axess Vision Technology

SRN

FR-MF-000003039

Manufacturer status

Active

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

• CW009

  EUDAMED did not publish a description for this code.
• CW001

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

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 17 countries total.

Trade name

not provided

UDI-DI code

03664977000103

Basic UDI-DI

3664977EMDNZ12020802PF

Reference / catalog number

10040001

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

Broncoflex™ is a single use video bronchoscope which is part of a system made up of the endoscope (Broncoflex™) and its reusable display monitor (Screeni™). It is designed for use exclusively in a hospital environment. Broncoflex™ permits the visualization of the inside of the airways for therapeutic purposes. The Broncoflex™ is sterile and supplied ready to use in its packaging which is composed of a protective tube with a pouch. The consumables are supplied in sets of 5 in a carton. Inside this box, each ETO-sterilized consumable is placed in a single package. The Broncoflex™ are provided Ethylene Oxide (EtO) sterilized for single use with a 3-years shelf life.

Additional information URL

https://www.tsc-life.com/products/broncoflex/

Clinical sizes

No clinical sizes registered for this device.

• Z12020802VIDEO BRONCHOSCOPES

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

Certificate health across this manufacturer's portfolio.