Organization name

Meril Life Sciences Pvt. Ltd.

SRN

IN-MF-000008308

Manufacturer status

Active

6 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.
• 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.
• CW026

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 13 countries total.

Trade name

Flomero™

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.

18904224930732

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.

89042249PBE8

Reference / catalog number

FLOM19A

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

An Aortic Flomero™ Pericardial Bioprosthesis is comprised of three leaflets made from bovine pericardial tissue, a frame and a sewing ring. The frame is comprised of a polymer ring (support ring), PET film structures (posts or commissures) and a frame made of Elgiloy* alloy wireform. These three components of frame are covered with polyester fabric. The frame is designed to be compliant at the orifice and commissures. A sewing ring made from polyester fabric is attached to the covered frame. Three contrasting markings are located on this sewing ring. These markings aid in proper orientation for implantation of the prosthesis.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 19 MU50

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

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

• P070301010201STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.