Tumbling E, Runge Design Pocket Near Vision Card, for testing at 40cm (16 in.)

Organization name

Precision Vision, Inc.

SRN

US-MF-000008456

Manufacturer status

Active

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

Primary placement in Netherlands; available across 1 country total.

Trade name

Tumbling E, Runge Design Pocket Near Vision Card, for testing at 40cm (16 in.)

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.

00811286032995

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.

081128603PVChartsLF

Reference / catalog number

2307

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

Tumbling E, Runge Design Pocket Near Vision Card, for testing at 40cm (16 in.)

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.

• Z1212012099INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - OTHER

• Class I medical devices in EUDAMED