Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001159036

FEI Number

3001159036

Entity Name

CONFORTEX, S.A.

City/State/Country

SAN JOSE, CR

Establishment Address

del la escuela publica de Guachipelin, de Escazu 200mts norte y 75 mts oeste, SAN JOSE 0, CR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CONFORTEX, S.A. (Owner Number: 10040436)

Owner / Operator Contact Address

del la escuela publica de Guachipelin, de Escazu 200mts norte y 75 mts oeste, SAN JOSE, CR-SJ 0, CR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Forefoot Compression Arch Binder Arch Bandage Hallux Splint (SL,SR,ML,MR,LL,LR) Medtri-Pad (SR,SL,LR,LL) Toe Cap (S,M,L) Bunion Shield (L/R)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2025-04-25
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2025-04-25
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2025-04-25
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2025-04-25

Official Correspondent

ALVARO SANCHO

US Agent Details

DENNIS CASE Business: PEDIFIX, INC. Email: dennis.case@pedifix.com Phone: (845) 2772850

Related Public Records

Same Entity

CONFORTEX, S.A.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3005423373	TRI-FI KNITTING, LLC	Dunlap, TN, US
3008973900	SAFECARE MEDICAL PRODUCTS CO., LTD. (HEFEI)	HEFEI Anhui, CN
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3015414796	COMPRESS INNOVATIONS, LLC	Manhasset, NY, US
3004651767	CLEARPOINT MEDICAL	Lachine Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001159036. Last updated year: 2026. Please use registration number 3001159036 when referencing this establishment in official correspondence.