Organization name

Romsons Group Private Limited

SRN

IN-MF-000036506

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Consult instructions for use

Primary placement in Austria; available across 32 countries total.

Trade name

CLOSED WOUND DRAINAGE SYSTEM

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.

08907265013139

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.

8907265G001ZD

Reference / catalog number

GS-5002 KAD

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

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

CLOSED WOUND DRAINAGE SYSTEM, 800ML BELLOW SUCTION UNIT, REDON DRAIN CATHETERS, CURVED TROCAR, SIZE: 14 FG

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 14 MU170

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

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

• A0601010102DRAINAGE SYSTEMS WITH RESERVOIR

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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