IOL MINI WELL TORIC +31.5SE CL3.5

Organization name

SIFI S.p.A.

SRN

IT-MF-000020853

Manufacturer status

Active

• 028-00-02-MDRSupplemented
  Technical documentationNotified body: 0426Expiry: Aug 31, 2028

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

• CW011

  EUDAMED did not publish a description for this code.
• 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.
• CW020

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

  EUDAMED did not publish a description for this code.
• CW999

  See IFU

Primary placement in Italy; available across 10 countries total.

Trade name

IOL MINI WELL TORIC +31.5SE CL3.5

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.

08027864069679

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.

8027864SIFIMDF33NA

Reference / catalog number

X7560CZ

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

MINI WELL TORIC is an acrylic aspherical EDOF toric intraocular lens sold together with Accuject PRO 1.8-1P injector in procedural pack configuration. This UDI-DI is applicable to the model X7560CZP315K3 with +31.5SE CL3.5

Additional information URL

https://qr.sifigroup.com/4INSERTPIOLTMDR/

Clinical sizes

• Spherical Equivalent — 31 MU104
• 3.5 MU104

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

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

• P030102100302IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHILIC ACRYLIC

• Class IIb medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.