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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

Helenvision Lite — Class IIb MDR by C.O.C. FARMACEUTICI…

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

EUDAMED last updated this device on Feb 23, 2026

Helenvision Lite

803395976DT01DT008ZP

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: 08057729510909
Reference / catalog number: DT/01/DT/008

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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

Critical warnings

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

CW999
Product is for ophthalmic use only.
CW262
Product is for single patient use [EN].
CW999
During application, do not touch eye or any other surface with the container’s dispensing edge.
CW999
For external use, do not swallow.
CW999
Do not use in case of known incompatibility towards any of the ingredients and/or Apiaceae plants.
CW999
Dispose of the product according to your local waste management regulations
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
Helenvision Lite does not substitute any drug that may be prescribed by the doctor.
CW007
Do not use the product if container is damaged or not perfectly closed when you open it for the first time [EN].
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
Keep out of the reach and sight of children.
CW999
Do not tamper with or damage the bottle and its mechanisms.
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
Do not use if are visible particles and/or changes in the color of the solution.
CW277
In case of side effects during use, interrupt the treatment and consult a doctor [EN].
CW032
Do not use the product after the expiry date indicated on the package [EN].
CW275
Consult your doctor before you use this product if you are pregnant or breast-feeding [EN].

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Market distribution

Primary placement in EL; available across 1 country total.

Country	On market since	Until
ELPrimary placement		Still on market

Device identification

Trade name: Helenvision Lite
UDI-DI code: 08057729510909
Basic UDI-DI: 803395976DT01DT008ZP
Reference / catalog number: DT/01/DT/008
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)08057729510909

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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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Related devices

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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.