Organization name

Wenzhou Focuseyewear Co., Ltd.

SRN

CN-MF-000050829

Manufacturer status

Active

Primary placement in Netherlands; available across 32 countries total.

Trade name

READING GLASSES

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.

06975890063708

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.

697589006MQ2011005FEG

Reference / catalog number

06975890063708

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 I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

This collection of presbyopic glasses features PC, metal and hybrid materials that combine modern design, durability and comfort. Diverse styles, different face shapes and styles, in line with international quality standards, is the ideal choice for both quality and practicality.

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.

• Q0210010102MULTIFOCAL ORGANIC OPHTHALMIC LENSES (BIFOCAL, TRIFOCAL)

• Class I medical devices in EUDAMED

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