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

OF80LTF003 — Class IIa MDD by ITALDEVICE S.R.L.

MD Atlas
ITALDEVICE S.R.L.

EUDAMED last updated this device on Feb 6, 2025

OF80LTF003

B-ITMF26487OF80LTF003YM

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ITALDEVICE S.R.L.
UDI-DI code: D-ITMF26487OF80LTF003YM
Reference / catalog number: OF80LTF003

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: ITALDEVICE S.R.L.
SRN: IT-MF-000026487
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW275
In very rare cases, in patients with severely damaged ocular surface, the use of phosphate-containing ophthalmic solutions has been associated with corneal calcification. Therefore, consult your specialist before administering the product in case of band keratopathy or calcium deposits on the cornea.

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	Oct 4, 2019	Dec 31, 2028

Device identification

Trade name: not provided
UDI-DI code: D-ITMF26487OF80LTF003YM
Basic UDI-DI: B-ITMF26487OF80LTF003YM
Reference / catalog number: OF80LTF003
Issuing entity: EUDAMED

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: sample unit 3 ml
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

D-ITMF26487OF80LTF003YM

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Q02030206EYE LUBRICANT SOLUTIONS

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

Related devices

NP70APP002B-ITMF26487NP70APP0022POn the market NP70APP005B-ITMF26487NP70APP0052VOn the market NP70APP001B-ITMF26487NP70APP0012MOn the market AEON PROTECT PLUSB-ITMF26487NP70APP0032ROn the market OP90ALR008B-ITMF26487OP90ALR00848On the market

Certificates

Certificate health across this manufacturer's portfolio.

0425-MDR-030103-00Issued
Quality management systemNotified body: 0425Expiry: Nov 5, 2029