Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027437074

FEI Number

3027437074

Entity Name

FISBOL INTERNATIONAL S.A.

City/State/Country

Montevideo, UY

Establishment Address

Ruta 8 km 17500, Edificio Costa Park, Zonamerica, Montevideo 91600, UY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FISBOL INTERNATIONAL S.A. (Owner Number: 10088083)

Owner / Operator Contact Address

Ruta 8 km. 17500, Edificio Costa Park, Zonamerica, Montevideo, UY-MO 91600, UY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pressure Probe (BA-A-008) Pediatric Pressure Probe (BA-P-006) Double Balloon for Esophageal and Gastric Pressure Measurement (BB-A-010) Pressure Probe Small (BA-A-006) Flow Sensor Adult (SF-A-022)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBA	Catheter, Balloon Type	General, Plastic Surgery	Class 1	878.4200	2023-05-23
JAX	Pneumotachometer	Anesthesiology	Class 2	868.2550	2023-05-23

Official Correspondent

No official correspondent registered.

US Agent Details

Jose Huerta Business: SANRUBIO Email: info@sanrubio.com Phone: (786) 5578049

Related Public Records

Same Entity

FISBOL INTERNATIONAL S.A.

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 3027437074. Last updated year: 2026. Please use registration number 3027437074 when referencing this establishment in official correspondence.