Organization name

HASA OPTIX

SRN

BE-MF-000028219

Manufacturer status

Active

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

• Do not use if package is damaged

Primary placement in Belgium; available across 32 countries total.

Trade name

HASA OPTIX

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.

05404027424873

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.

B-05404027424873

Reference / catalog number

554038

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

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Box of 10 Sterile Pieces

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

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

• Q021199OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER

• Class IIb medical devices in EUDAMED

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