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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

AQUALARM ÉCRAN — Class IIb MDR by C.O.C. FARMACEUTICI…

MD Atlas
C.O.C. FARMACEUTICI S.R.L.

EUDAMED last updated this device on Mar 5, 2026

AQUALARM ÉCRAN

803395976DT01DT007ZM

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: C.O.C. FARMACEUTICI S.R.L.
UDI-DI code: 03614790001504
Reference / catalog number: DT/01/DT/007

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View device family (Basic UDI)

Manufacturer information

Organization name: C.O.C. FARMACEUTICI S.R.L.
SRN: IT-MF-000019321
Manufacturer status: Active

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

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

CW275
Consult your doctor before you use this product if you are pregnant or breast-feeding [EN].
CW999
For external use, do not swallow.
CW999
Do not try to tamper or disassemble the nozzle from the bottle.
CW999
It is necessary to report any serious incident occurred in relation to the device to the manufacturer and the Competent authority of the Member state in which you are established.
CW999
Product is for external ophthalmic use only.
CW262
Product is for single patient use [EN].
CW007
Do not use the product if container is damaged or not perfectly closed when you open it for the first time [EN].
CW032
Do not use the product after the expiry date indicated on the package [EN].
CW999
Do not use in case of known incompatibility towards any of the ingredients.
CW999
If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.
CW999
n case of side effects during use, interrupt the treatment and consult a doctor;
CW036
No interactions with drugs or other eye drops are reported; however, leave at least 15 minutes between administrations of any other eye drops [EN].
CW999
Do not use if there are visible particles and/or changes in the color of the solution.
CW999
During application, do not touch eye or any other surface with the container’s dispensing edge.
CW999
Dispose of the product according to your local waste management regulations.
CW999
Keep out of the reach of children.

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Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: AQUALARM ÉCRAN
UDI-DI code: 03614790001504
Basic UDI-DI: 803395976DT01DT007ZM
Reference / catalog number: DT/01/DT/007
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: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
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)03614790001504

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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.

Q0299OPHTHALMIC DEVICES - OTHER

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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