PBASS1927

Organization name

Meril Life Sciences Pvt. Ltd.

SRN

IN-MF-000008308

Manufacturer status

Active

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

• Do not use if package is damaged
• Consult instructions for use

Primary placement in Germany; available across 13 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.

18904224958163

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

PBASS1927

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

Pericardial Bioprosthesis – Aortic Sizer is used to help doctor accomplish cardiac valve operation. It consists of sizer and handle. Sizer is designed to confirm the size of patient’s aortic valve to select the correct size of prosthetic valve

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 19–27 MU50

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

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

• P07038001HEART VALVE IMPLANT SIZERS

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.