Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005748450

FEI Number

3005748450

Entity Name

EDSER INSOLES S.L.

City/State/Country

ESPLUGUES DE LLOBREGAT Barcelona, ES

Establishment Address

C/GALL,47,ENTLO.POL.IND. GALL, BARCELONA, ESPLUGUES DE LLOBREGAT Barcelona 08950, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EDSER INSOLES S.L. (Owner Number: 9087661)

Owner / Operator Contact Address

C/GALL,47,ENTLO.POL.IND. GALL, BARCELONA, ESPLUGUES DE LLOBREGAT, ES-B 08950, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EDSER UE Immobilizer EDSER UE Immobilizer EDSER Forearm Guard EDSER Shin Guard EDSER Limb Protection TLSO Spinal Brace EDSER Orthoses EDSER Protective Mask LSO Spinal Brace Barcelona AFO EDSER AFO Miami AFO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2023-03-29
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2023-03-29
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2023-03-29
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2025-12-13
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2006-05-24
NDA	Helmet, Cranial, For Protective Use	Physical Medicine	Class 1	890.3025	2023-03-29
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2025-12-13
OHI	Orthosis, Foot Drop	Physical Medicine	Class 1	890.3475	2023-03-21

Official Correspondent

SERGIO SANCHEZ OSORIO

US Agent Details

Jamison Goldberg Business: Euroinsoles Incorporated Email: jgoldberg@edserlabs.com Phone: (305) 8157442

Related Public Records

Same Entity

EDSER INSOLES S.L.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005748450. Last updated year: 2026. Please use registration number 3005748450 when referencing this establishment in official correspondence.