EUDAMED last updated this device on Aug 5, 2026

EYESTIL GEL

8027864SIFIMDF11MY

On the marketClass IIb

Applicable legislation: —
Organization name: SIFI S.p.A.
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08027864000702
Reference / catalog number: HA GEL

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

EYESTIL GEL is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by SIFI S.p.A.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: EYESTIL GEL
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08027864000702
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. View in glossary →: 8027864SIFIMDF11MY
Reference / catalog number: HA GEL
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class IIb
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: HA GEL is a sterile and transparent eye gel, preservative free, containing two natural polymers: sodium hyaluronate and xanthan gum. After instillation in the conjunctival sac, HA GEL mixes with tears and forms a lubricating, viscous and transparent layer, reducing friction due to eye movements and blinking. HA GEL alleviates the symptoms of ocular dryness due to environmental and climatic conditions such as pollen, dust, glare, pollution, computer monitor use. HA GEL also protects the ocular surface during wound or abrasion healing processes
Additional information URL: https://qr.sifigroup.com/1G809070/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08027864000702

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

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

Q0299OPHTHALMIC DEVICES - OTHER

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

Consult instructions for use
Do not re-use
Do not use if package is damaged
Product interactions with the administration of other ophthalmic drugs are unknown. However, due to the physical properties of the gel, it is advised to not administer other drugs or medical devices for ocular use within 60 minutes after instillation of HA GEL. The concomitant use of therapeutic contact lenses after photorefractive keratectomy (PRK) surgery resulted to be compatible with the use of the product. However, the use of other kinds of contact lenses is advised only 60 minutes after the application of HA GEL.
OTHER

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Italy; available across 3 countries total.

Country	On market since	Until
ItalyPrimary placement	—	Still on market
Spain	—	Still on market
Poland	—	Still on market

EYESTIL GEL

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

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Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

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Market distribution

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Manufacturer information

Certificates

Certificates covering this device

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