Organization name

NOVATECH SA

SRN

FR-MF-000001658

Manufacturer status

Active

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

• CW007

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

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

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

  EUDAMED did not publish a description for this code.
• CW025

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 23 countries total.

Trade name

not provided

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.

14063108100464

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.

B-14063108100464

Reference / catalog number

03161FS

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Tracheo-bronchial silicone stent TF 12 L 40

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 12 MU50
• 40 MU50

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

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

• P0401TRACHEOBRONCHIAL PROSTHESES

• Class IIb medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.