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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

DT/01/DT/006 — Class IIb MDR by C.O.C. FARMACEUTICI…

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

EUDAMED last updated this device on Feb 9, 2026

DT/01/DT/006

803395976DT01DT006ZK

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: 08033959761168
Reference / catalog number: DT/01/DT/006

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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

Related devices

DT/01/DT/002803395976DT01DT002ZBOn the market DT/01/DT/002803395976DT01DT002ZBOn the market DT/01/DT/002803395976DT01DT002ZBOn the market DT/01/DT/002803395976DT01DT002ZBOn the market DT/01/DT/003803395976DT01DT003ZDOn the market

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

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

CW007
Do not use the product if container is damaged or not perfectly closed when you open it for the first time [EN].
CW999
During application, do not touch eye or any other surface with the container’s dispensing edge.
CW999
Product is for ophthalmic use only.
CW999
The product is usually intended for continuous use for no more than 30 days; if symptoms persist consult your doctor.
CW262
Product is for single patient use [EN].
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
Dispose of the product according to your local waste management regulations.
CW999
For external use, do not swallow.
CW999
Do not use if are visible particles and/or changes in the color of the solution.
CW032
Do not use the product after the expiry date indicated on the package [EN].
CW999
Keep out of the reach and sight of children.
CW999
Do not use in case of known incompatibility towards any of the ingredients.
CW999
Do not try to tamper or disassemble the nozzle from the bottle.
CW999
The device is not indicated for treatment of infection and other ocular diseases. These conditions require medical attention.
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].
CW275
Consult your doctor before you use this product if you are pregnant or breast-feeding [EN].
CW277
In case of side effects during use, interrupt the treatment and consult a doctor [EN].

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Market distribution

Primary placement in Italy; available across 2 countries total.

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

Device identification

Trade name: not provided
UDI-DI code: 08033959761168
Basic UDI-DI: 803395976DT01DT006ZK
Reference / catalog number: DT/01/DT/006
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: FREE SAMPLE
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)08033959761168

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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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