Organization name

Hangzhou Hawk Optical Electronic Instruments Co.,Ltd.

SRN

CN-MF-000028791

Manufacturer status

Active

Primary placement in Bulgaria; available across 30 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.

06947014622191

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.

69470146RJ00052110RC

Reference / catalog number

T8199

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

Telescope 90°,Φ8 x 188 mm

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Φ8mm

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12021006VIDEO NASOPHARYNGO/LARYNGOSCOPES

• Class I medical devices in EUDAMED

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