Neochromes ONE HI 1.60 UC Camber Gray 0.50

Organization name

Advanced Photochromics LLC

SRN

US-MF-000043049

Manufacturer status

Active

Primary placement in Spain; available across 10 countries total.

Trade name

Neochromes ONE HI 1.60 UC Camber Gray 0.50

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.

18404975007351

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.

081016109160CamberOnePW

Reference / catalog number

0265023754

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

https://page.iotlenses.com/hubfs/Instructions_Neochromes.pdf

Clinical sizes

• 0.5 MU104

1 packaging level registered — each level carries its own UDI-DI.

• 18404975007351× 1 unitBase unit
  • 28404975007358× 40 units

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

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

• Q0210010101MONOFOCAL ORGANIC OPHTHALMIC LENSES

• Class I medical devices in EUDAMED

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