Organization name

Meril Life Sciences Pvt. Ltd.

SRN

IN-MF-000008308

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW267

  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.
• CW026

  EUDAMED did not publish a description for this code.

Primary placement in Austria; available across 21 countries total.

Trade name

Myval OCTACOR™

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.

18904224954929

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-18904224954929

Reference / catalog number

MOCTA2320

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

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

Status

On the market

Quantity

1

Additional product description

A balloon expandable Transcatheter Heart Valve consisting of a) a frame of Cobalt-Nickel- Chromium-Molybdenum Alloy, b) a tri-leaflet valve made from fixed bovine pericardial tissue and c) inner and outer fabric covers. It is used for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis as judged by a heart team (including a cardiac surgeon) and in patients who are at a risk for open heart surgical therapy.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 31 MU50

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

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

• P070301030201STENTED BIOLOGICAL AORTIC VALVES FOR PERCUTANEOUS IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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