AJL OCULAR

Organization name

AJL OPHTHALMIC, S.A

SRN

ES-MF-000000267

Manufacturer status

Active

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• Consult instructions for use

Primary placement in Spain; available across 13 countries total.

Trade name

AJL OCULAR

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.

08435194320795

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.

84351943018SJ

Reference / catalog number

CF-M-AJL

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

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The Perforated Conformer is a medical device that is used after surgical procedures such as enucleation or evisceration. It is made of a highly resistant thermoplastic polyethylene and copolyester material (PTEG), which is transparent to allow visualisation of the conjunctiva. The Perforated Conformer has a concave shape that fits the eye socket and has two holes to aid the drainage of secretions and the administration of drops and medication.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Espesor — 1.2 MU50
• 24 MU50
• 21 MU50

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

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

• Q0299OPHTHALMIC DEVICES - OTHER

• Class IIa medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.