Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

DT/01/DT/003 — Class IIb MDR by C.O.C. FARMACEUTICI…

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

EUDAMED last updated this device on Mar 24, 2023

DT/01/DT/003

803395976DT01DT003ZD

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: 08052432890874
Reference / catalog number: DT/01/DT/003

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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

16 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
Product is for ophthalmic use only
CW262
Product is for single patient use
CW007
Do not use the product if container is damaged or not perfectly closed when you open it for the first time
CW999
Do not use if 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
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
Do not use in case of known incompatibility towards any of the components of the solution and/or Ericaceae plants and/or Apiaceae plants and/or Anacardiaceae plants and/or Poison Ivy and/or celery
CW036
No interactions with drugs or other eye drops are reported; however, leave at least 15 minutes between administrations of any other eye drops
CW999
Dispose of the product according to your local waste management regulations
CW999
Keep out of the reach and sight of children
CW275
Consult your doctor before you use this product if you are pregnant or breast-feeding
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

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08052432890874
Basic UDI-DI: 803395976DT01DT003ZD
Reference / catalog number: DT/01/DT/003
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

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

Become a partner of MD Atlas