Organization name

66 VISION TECH CO., LTD.

SRN

CN-MF-000030050

Manufacturer status

Active

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

• Consult instructions for use

  Not suitable for infants

Primary placement in Austria; available across 32 countries total.

Trade name

Direct Ophthalmoscope

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.

06951090800428

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.

69510908YZ116SV

Reference / catalog number

336289362401

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

The Direct Ophthalmoscope is a medical optical instrument suitable for examining the fundus and measuring the location of foreign bodies in the eye and the scope of lesions.

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.

• Z12120114OPHTHALMOSCOPES

• Class I medical devices in EUDAMED

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