Organization name

WENZHOU INTERNATIONAL ECO. & TEC. COOPERATION CO., LTD

SRN

CN-MF-000023985

Manufacturer status

Active

Primary placement in Germany; available across 32 countries total.

Trade name

OPTICAL FRAMES

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.

06976933370029

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.

697693337AHC

Reference / catalog number

06976933370029

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

High-quality optical frames made from acetate, stainless steel, or titanium, combining modern design, durability, and comfort. Available in various styles, shapes, and colors, they suit different face types and are suitable for both prescription and sunglasses lenses. A versatile product aimed at both retail and wholesale markets, complying with international quality standards.

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.

• Q02100203METAL AND PLASTIC SPECTACLE FRAMES WITHOUT LENSES

• Class I medical devices in EUDAMED

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