Organization name

MedOne Surgical, Inc.

SRN

US-MF-000002763

Manufacturer status

Active

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

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

• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.

Primary placement in Austria; available across 30 countries total.

Trade name

PolyVent™ Cannula 23g/38g

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.

00811313013065

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.

081131301MEDSURG01QY

Reference / catalog number

3306

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

Sterile Cannula Family

Additional information URL

https://www.medone.com/

Clinical sizes

• 23 MU999

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

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

• Q021101OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.