Organization name

Oculo-Plastik, Inc.

SRN

CA-MF-000022997

Manufacturer status

Active

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

• Refer to instruction manual/booklet

Primary placement in Netherlands; available across 32 countries total.

Trade name

Plastic Ocular Shield (large), black

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.

10697660003105

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.

697660100US

Reference / catalog number

23-206

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

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 25.5 MU50
• 28.5 MU50

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

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

• T0306PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES

• Class I medical devices in EUDAMED

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