Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ 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

Gel toe spreader & bunion protector — Class I MDR

MD Atlas
Fresco International 2005, S.A.

EUDAMED last updated this device on May 7, 2026

Gel toe spreader & bunion protector

84350579F000422E

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fresco International 2005, S.A.
UDI-DI code: 05206680001251
Reference / catalog number: F-00042-54CNP

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?

Manufacturer information

Organization name: Fresco International 2005, S.A.
SRN: ES-MF-000010728
Manufacturer status: —

Market distribution

Primary placement in EL; available across 1 country total.

Country	On market since	Until
ELPrimary placement		Still on market

Device identification

Trade name: Gel toe spreader & bunion protector
UDI-DI code: 05206680001251
Basic UDI-DI: 84350579F000422E
Reference / catalog number: F-00042-54CNP
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: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y090699DEVICES FOR BODY PROTECTION - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Cone for 5th toe84350579F000412COn the market Gel Bunion Sleeve84350579F000422EOn the market Gel bunion spreader & ring, Small84350579F000542MOn the market Gel heel, 2 hardness, Large84350579F000672WOn the market Gel heel, 2 hardness, Medium84350579F000672WOn 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.