Organization name

66 VISION TECH CO., LTD.

SRN

CN-MF-000030050

Manufacturer status

Active

Primary placement in France; available across 32 countries total.

Trade name

Operation Microscope

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.

06951090800084

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.

695109080YZ20JV

Reference / catalog number

XI-AR-000001836

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

A operation microscope is specifically designed for use in the surgical environment and typically used to perform microsurgery. The operation microscope is equipped with high-precision optical components, allowing doctors to observe the patient's anatomical structure at high magnification, and to clearly see the most complex details with high resolution and high contrast, thereby helping doctors perform high-precision surgical operations.

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.

• Z12011101OPERATIVE MICROSCOPES

• Class I medical devices in EUDAMED

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