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Organization name
UDI-DI code
Reference / catalog number

9030379 — Class IIb MDR by Farmigea S.p.A.

MD Atlas
Farmigea S.p.A.

EUDAMED last updated this device on May 22, 2026

9030379

80326688700004SK

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Farmigea S.p.A.
UDI-DI code: 08032668872936
Reference / catalog number: 9030379

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View device family (Basic UDI)

Manufacturer information

Organization name: Farmigea S.p.A.
SRN: IT-MF-000018521
Manufacturer status: Active

Related devices

903030880326688700004SKOn the market 903230880326688700004SKOn the market 911230880326688700004SKOn the market 911030880326688700004SKOn the market 911037980326688700004SKOn the market

Certificates

Certificate health across this manufacturer's portfolio.

57320Supplemented
Quality management systemNotified body: 0546Expiry: Mar 11, 2030
56317Reissued
Quality management systemNotified body: 0546Expiry: Nov 27, 2028
56318Issued
Quality management systemNotified body: 0546Expiry: Nov 27, 2028
56317Issued
Quality management systemNotified body: 0546Expiry: Nov 27, 2028
CSQ001123Issued
Quality management systemNotified body: 0373Expiry: Jun 13, 2028

Critical warnings

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

CW135
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW304
EUDAMED did not publish a description for this code.
CW999
The product is for externalophthalmic use only. Do not use if the mini-container isdamaged. Do not use in case of known incompatibility toany of the ingredients of the preparation. One opened,each mini-container can be used for up to 12 hours. Thecontent of each singlese dose container should be used by one person only. Leave at least 10-15 minutes beforeadministration of any other ophthalmic drugs
CW007
EUDAMED did not publish a description for this code.
CW166
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Nov 10, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08032668872936
Basic UDI-DI: 80326688700004SK
Reference / catalog number: 9030379
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 30
Additional product description: Aquoral Forte 30 mini-containers is an ophthalmic solution of TS-Polysaccharide and high-molecular weight Sodium Hyaluronate, produced through biotechnological synthesis, used to obtain long lasting relief from dry eyes.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 0.5 MU03

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08032668872936

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UDI-PI DataMatrix

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

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EMDN nomenclature code(s)

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

Q02030206EYE LUBRICANT SOLUTIONS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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