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

05475 — Class I MDR by Gabbiano S.p.A.

MD Atlas
Gabbiano S.p.A.

EUDAMED last updated this device on Sep 29, 2025

05475

803256811M05474QT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Gabbiano S.p.A.
UDI-DI code: 08023766054751
Reference / catalog number: 05475

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: Gabbiano S.p.A.
SRN: IT-MF-000020347
Manufacturer status: Active

Related devices

Farmamed Bandage en filet tubulaire803256811M05401PYOn the market 05413803256811M05413Q7On the market 05512803256811M05417QFOn the market Farmamed Pansement Aqua No Problem avec protection bactériostatiqueB-08023766053235On the market Farmamed Pansement Articulations avec protection bactériostatiqueB-08023766053259On 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

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

CW999
durante l’utilizzo delle solette è consigliato indossare una calza o indumento simile. Non utilizzare su ferite o pelle lesa o arrossata. Si raccomanda di effettuare revisioni periodiche per determinare il buono stato delle solette. Non utilizzare in presenza di segni di evidente usura o anomalia. Interrompere l’utilizzo in caso di reazione avversa. Non sottoporre mai le solette a fonti di calore. Conservare a temperatura ambiente.

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 2 countries total.

Country	On market since	Until
ItalyPrimary placement	Aug 1, 2023	Still on market
Spain	Aug 1, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08023766054751
Basic UDI-DI: 803256811M05474QT
Reference / catalog number: 05475
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 2
Additional product description: La plantilla Farmamed está diseñada para ayudar al pie a mantener una posición correcta, evitando así que surjan problemas en otras partes del cuerpo. El diferente grosor entre el talón y la punta de la plantilla ayuda a mejorar el baricentro y a distribuir mejor el peso en los tres puntos cruciales del pie: el talón, el primer y el quinto metatarsiano. El tejido, fabricado con tecnología FIR, ayuda a mejorar la microcirculación sanguínea.
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)08023766054751

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

Sign in to generate the UDI-PI DataMatrix

Create a free account, then generate the compliant UDI-PI carrier for this device.

Email

Password

No account yet?

EMDN nomenclature code(s)

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

Y061203ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)

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