AJL OCULAR

Organization name

AJL OPHTHALMIC, S.A

SRN

ES-MF-000000267

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.

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.

08435194320856

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.

84351943012S6

Reference / catalog number

SF-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 AJL Symblepharon Ring is an oculoplasty device designed to prevent retraction of the conjunctival cul-de-sac. It is ring-shaped so that it can be placed in the conjunctival sac of the eye, with the central width of the opening preventing contact with the cornea and thus protecting it. It is made of a highly resistant thermoplastic polyethylene and copolyester material (PTEG), which is translucent for easier visualisation of the conjunctiva.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 21 MU50
• 24 MU50
• Espesor — 1.2 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.