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

195800 — Class III MDD by Fidia Farmaceutici S.p.A.

MD Atlas
Fidia Farmaceutici S.p.A.

EUDAMED last updated this device on May 15, 2026

195800

B-195800QJ

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Fidia Farmaceutici S.p.A.
UDI-DI code: D-195800QJ
Reference / catalog number: 195800

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: Fidia Farmaceutici S.p.A.
SRN: IT-MF-000026988
Manufacturer status: Active

Related devices

10000914B-100009143ROn the market 1300126480336618004030100000000QEOn the market 1300126380336618004030100000000QEOn the market 114340B-114340M6On the market 10000307B-100003072WOn 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

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

CW999
It is suggested not to use the product for a period longer than 30 days
CW999
Consult your physician in case of infection complication. Tetracycline should not be used locally with BIONECT START.
CW999
Do not use the product concomitantly with soaps/detergents, disinfectants containing quaternary ammonium salts, silver and other heavy metals, which can reduce the action of the product. Ask your physician the possible products to be used.
CW999
Do not use on exposed cartilage or tendons.
CW999
Avoid contact with eyes and mucosae.
CW999
In case of accidental ingestion or inhalation consult the physician immediately.
CW999
Avoid the direct contact of the container with the wound.
CW999
After each application put the cap back on the container.
CW007
EUDAMED did not publish a description for this code.
CW999
The product can be used up to 36 months after the first opening of the tube
CW032
EUDAMED did not publish a description for this code.
CW999
After use, dispose according to applicable national regulations.
CW999
Keep out of sight and reach of children.

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		Dec 31, 2027

Device identification

Trade name: not provided
UDI-DI code: D-195800QJ
Basic UDI-DI: B-195800QJ
Reference / catalog number: 195800
Issuing entity: EUDAMED

Classification

Risk category: Class III
Applicable legislation: MDD [Directive 93/42/EEC 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: 30 MU24

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-195800QJ

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.

M040499DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - 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