Organization name

Alcon Laboratories, Inc.

SRN

US-MF-000016248

Manufacturer status

Active

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

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

• Do not re-use
• Contains hazardous substances
• Do not use if package is damaged
• Consult instructions for use

Primary placement in Belgium; available across 31 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.

07612717071216

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.

038065GMN000153H5

Reference / catalog number

337.86

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

—

Additional information URL

https://www.ifu.alcon.com/

Clinical sizes

No clinical sizes registered for this device.

1 packaging level registered — each level carries its own UDI-DI.

• 07612717071216× 1 unitBase unit
  • 17612717071213× 6 units

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

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

• Z12120285THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - CONSUMABLES

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.