Organization name

SHANGHAI HWALLONE OPTICS CO.,LTD

SRN

CN-MF-000040554

Manufacturer status

Active

Primary placement in Austria; available across 32 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.

06977222950038

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.

697722295SpectaclelensB6

Reference / catalog number

1.67

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

—

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.

• Q0210010299MINERAL OPHTHALMIC LENSES - OTHER
• Q0210010203PROGRESSIVE MINERAL OPHTHALMIC LENSES
• Q0210010202MULTIFOCAL MINERAL OPHTHALMIC LENSES (BIFOCAL, TRIFOCAL)
• Q0210010201MONOFOCAL MINERAL OPHTHALMIC LENSES
• Q0210010199ORGANIC OPHTHALMIC LENSES - OTHER
• Q0210010103PROGRESSIVE ORGANIC OPHTHALMIC LENSES
• Q0210010102MULTIFOCAL ORGANIC OPHTHALMIC LENSES (BIFOCAL, TRIFOCAL)
• Q0210010101MONOFOCAL ORGANIC OPHTHALMIC LENSES

• Class I medical devices in EUDAMED

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