Organization name

Meril Life Sciences Pvt. Ltd.

SRN

IN-MF-000008308

Manufacturer status

Active

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

• CW010

  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 Türkiye; available across 11 countries total.

Trade name

Mozec™ PTA 0.035" OTW

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.

18904224911366

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-18904224911366

Reference / catalog number

MO35090060A

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 IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Mozec™ PTA OTW Balloon Dilatation Catheter consists of a Balloon (dilatation element) near the distal tip with radiopaque marker bands, which represent the approximate balloon working length at nominal pressure. The proximal end has a Y luer hub for balloon inflation. The catheter has a soft tip at the distal end. Dual lumens shaft which permit movement of guide wire and balloon inflation. The distal portion of the shaft has hydrophilic coating applied on it, in order to facilitate catheter advancing through the vascular district and the vessel stenosis.The compliance chart on the inner and outer label indicates how the balloon diameter increases with increasing pressure. The compliance data is based on in vitro testing of balloons at 37°C temperature. Guide wire compatibility: 0.035”. The Mozec PTA Balloon Dilatation Catheter is available in different balloon sizes. Nominal balloon diameters and lengths are printed on the hub.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 60 MU50
• 9 MU50

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

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

• C010401020101PTCA BALLOON DILATION CATHETERS

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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