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FRESCO INTERNATIONAL 2005, S.A.

Spain · Barcelona · www.fresco.es

✓ Record-verifiedregistrations found in 8 marketsEU SRN ES-MF-000010728

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Australia, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

23UDI-DI device records

Class I 23

USUnited StatesFDA openFDA

4listed device types

Class I 4Class II 0Class III 0

plus 4 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

22registered device records

Class I 22

BRBrazilANVISA

4registered devices

Class I 4

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

10registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

1active registrations

Class 1 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union38 raw hits, 15 excluded, 23 confirmed

United States4 registration records, 0 510(k), 0 PMA

United Kingdom22 confirmed, 0 excluded

Brazil4 confirmed, 0 excluded

Saudi Arabia10 confirmed, 0 excluded

Manufacturer names merged into this page: FRESCO INTERNATIONAL 2005 S.A. · FRESCO INTERNATIONAL 2005, SA · Fresco International 2005, S.A. · FRESCO INTERNATIONAL 2005, S.A · Fresco International 2005 S.A.

Regulatory identity

EU manufacturer SRN: ES-MF-000010728
UK responsible person: Link3 Ltd

Business registration

Legal name: FRESCO INTERNATIONAL 2005 S.A.
LEI: 9598008NGBRK0UMX0X13
Registration status: Active
Legal form: Sociedad Anonima (S.A.)
Incorporated: 2004-12-03
Registration authority: Commercial Registry, no. 1000354795068
Registry record updated: 2026-08-21

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	05206680001268	Gel heel, 2 hardness, Small	Class I
EU	05206680001275	Gel heel, 2 hardness, Medium	Class I
EU	05206680001282	Gel heel, 2 hardness, Large	Class I
EU	05206680001169	Gel bunion spreader & ring, Small	Class I
UK	36295	Tube Toe Protector	Class I
UK	36295	Metatarsal Cushion	Class I
UK	36295	Bunion Protector	Class I
BR	81039450010	Gel de Silicone Medium	Class I
BR	81039450009	Gel de Silicone Hard	Class I
BR	81039450006	Gel de Silicone Soft	Class I
SA	ME0000012740SFDAA00007	FRESCO PROFESSIONAL Pressure Redistribution Pads	—
SA	ME0000012740SFDAA00008	Fresco PROFESSIONAL Silicone Gel Sheet	—

FRESCO INTERNATIONAL 2005, S.A.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA listed device types

Registration details (sample)

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