Organization name

Romsons International (Unit II)

SRN

IN-MF-000024594

Manufacturer status

Active

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

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

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 32 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.

08902120200419

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.

8902120B001RF

Reference / catalog number

GS-2004

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

Oral / Nasal Tracheal Tube with Cuff with Murphy Eye, Radio-opaque Line & Pilot Balloon, Dimension (ID): 5.0 mm

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 5 MU50

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

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

• R01030201ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.