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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/002 — Class IIb MDR by C.O.C. FARMACEUTICI…

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

EUDAMED last updated this device on Mar 2, 2026

DT/01/DT/002

803395976DT01DT002ZB

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: 08033959761038
Reference / catalog number: DT/01/DT/002

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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

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

CW999
The product contains the following CMR substances in concentrations above 0.1% w/w: boric acid and sodium tetraborate decahydrate. The product is not suitable for children, pregnant and breastfeeding women.
CW999
Do not use if are visible particles and/or changes in the color of the solution.
CW036
No interactions with drugs or other eye drops are reported; however, leave at least 15 minutes between administrations of any other eye drops.
CW007
Do not use the product if container is damaged or not perfectly closed when you open it for the first time.
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.
CW032
Do not use the product after the expiry date indicated on the package.
CW277
In case of side effects during use, interrupt the treatment and consult a doctor.
CW999
For external use, do not swallow.
CW999
Vision may be temporarily blurred. Minor burning/stinging/irritation may temporarily occur as a result of eye irritation. If any of these effects persist or worsen, tell your doctor immediately.
CW262
Product is for single patient use.
CW999
During application, do not touch eye or any other surface with the container’s dispensing edge.
CW999
Do not use in case of known incompatibility towards any of the ingredients or in case you are allergic to Asteraceae plants and/or Liliaceae plants and/or Ericaceae plants and/or Rosaceae plants.
CW999
Dispose of the product according to your local waste management regulations.
CW999
Keep out of the reach and sight of children.
CW999
Product is for ophthalmic use only.

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Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08033959761038
Basic UDI-DI: 803395976DT01DT002ZB
Reference / catalog number: DT/01/DT/002
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: 10
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

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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