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.
• CW264

  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.

Primary placement in Germany; available across 22 countries total.

Trade name

Proficient™

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.

18904224910406

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-18904224910406

Reference / catalog number

PRF22513

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

The Proficient™ Sirolimus Eluting Stent System comprises of following components -A balloon-expandable L605 Cobalt Chromium Coronary Stent -A stent coating that consists of a blend of anti-proliferative drug and polymers 1. Anti-proliferative drug Sirolimus (also known as Rapamycin) 2. Bio-compatible, bio-degradable co-polymer coating which acts as drug reservoir and drug release platform -A rapid-exchange stent delivery PTCA balloon catheter -The stent is pre mounted on balloon catheter & placed between two platinum-iridium radio opaque markers bands.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 2.25 MU50
• 13 MU50

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

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

• P070402010301CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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