Organization name

AUDIO TECHNOLOGIES SRL

SRN

IT-MF-000010733

Manufacturer status

Active

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

• Consult instructions for use
• Contains biological material of animal origin
• Do not re-use
• Do not resterilize
• Do not use if package is damaged
• Do not use past indicated date

Primary placement in Italy; available across 32 countries total.

Trade name

DURAMESH LYO

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.

08056138808881

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.

805714354FT0034V

Reference / catalog number

LYO-060X120H

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 III

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The “Collagen Matrices for Neurosurgery” product family comprises implantable medical devices made of collagen that are acellular, resorbable (i.e., biointegrated and subsequently biodegraded over time), sterile, and single-use, intended for use as dura mater grafts following surgical procedures on the skull and spine. They can replace dura mater that is missing due to its removal or retraction. The medical devices consist of acellular, preformed membranes, in various sizes, non-pyrogenic, freeze-dried, made of collagen derived exclusively from equine pericardial tissue.

Additional information URL

https://www.bio-synth.net/quality-regulatory

Clinical sizes

• 60 MU50
• 120 MU50

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

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.