Organization name

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

SRN

NL-MF-000015696

Manufacturer status

Active

Primary placement in Netherlands; available across 31 countries total.

Trade name

Eckardt TwinLight Chandelier with Photon connector and guidance needle (27 gauge / 0.4 mm)

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.

08717872016351

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.

B-08717872016351

Reference / catalog number

3269.PD27

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 IIa

Applicable legislation

MDD [Directive 93/42/EEC 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

• 27 Gauge

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

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

• Z12129085VARIOUS OPHTALMOLOGY INSTRUMENTS - CONSUMABLES

• Class IIa medical devices in EUDAMED

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