EASYSOFT

Organization name

LENTILLES

SRN

FR-MF-000006721

Manufacturer status

Active

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

• Caution
• Consult instructions for use
• Do not use if package is damaged
• Single patient multiple use

Primary placement in France; available across 13 countries total.

Trade name

EASYSOFT

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.

13664043000133

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.

36640434BC

Reference / catalog number

MANY

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

EASYSOFT Spheric H50

Additional information URL

https://www.lcs.guide/fr/notices-lentilles-de-contact/

Clinical sizes

• 7.8–10.5 MU50
• 12–16 MU50

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

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

• Q0210040102CONTACT LENSES - HYDROGEL, REUSABLE

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.