Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016854619

FEI Number

3016854619

Entity Name

ALACER INDUSTRIA ELETRONICA LTDA

City/State/Country

Sao Paulo, BR

Establishment Address

Rua Batista de Melo 113, Jardim Jabaquara, Sao Paulo 04383-080, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ALACER INDUSTRIA ELETRONICA LTDA (Owner Number: 10086657)

Owner / Operator Contact Address

Rua Batista de Melo 113, Jardim Jabaquara, Sao Paulo, BR-SP 04383-080, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K160170

PMA Number

N/A

All Registered Proprietary Names

AL-4 Catheter pHmetry Esophageal (2CpHAL4AD8cm) AL-4 Catheter pHmetry Esophageal (3CpHAL4AD15-20cm) pH Monitoring Probe (PH2C5CM) pH Monitoring Probe (PH2C19CM) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD15cm) AL-4 Catheter pHmetry Esophageal - External Reference (4PHAL4A101521UU) pH Monitoring Probe (PH2C16CM) AL-4 Catheter pHmetry Esophageal - External Reference (11PHAL4PD1,9UU) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD7CMUU) AL-4 Catheter pHmetry Esophageal (1CpHAL4AD) AL-4 Catheter pHmetry Esophageal - External Reference (4PHAL4A51520UU) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z20CMRE) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD20cm) pH Monitoring Probe (PH3C-13-24CM) pH Monitoring Probe (PH2C7CM) ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z7CMPDUU) ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z20CMUU) ZpH Catheter ImpedancepHmetry Esophageal (IG2PH6Z16CMUU) AL-4 Catheter pHmetry Esophageal - External Reference (1PHAL4AD1,4UU) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD12cm) pH Monitoring Probe (PH2C17CM) AL-4 Catheter pHmetry Esophageal (3CpHAL4AD7-23cm) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (IG2PH6Z14CMRE) AL-4 Catheter pHmetry Esophageal (4CpHAL4AD101821) AL-4 Catheter pHmetry Esophageal - External Reference (3PHAL4AD1520UU) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z22CMRE) AL-4 Catheter pHmetry Esophageal - External Reference (3PHAL4AD1519UU) pH Monitoring Probe (PH3C-7-23CM) pH Monitoring Probe (PH1C-PED1,9) AL-4 Catheter pHmetry Esophageal - External Reference (1PHAL4PD1,4UU) ZpH Catheter ImpedancepHmetry Esophageal (IG2PH6Z12CMUU) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD18CMUU) AL-4 Catheter pHmetry Esophageal (4CpHAL4AD51015cm) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (IG2PH6Z12CMRE) ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z10CMPDUU) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (2PH18_6Z18CMRE) AL-4 Catheter pHmetry Esophageal (3CpHAL4AD13-24cm) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD21CMUU) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD5cm) AL-4 Catheter pHmetry Esophageal (4CpHAL4AD101520) AL-4 Catheter pHmetry Esophageal (1CpHAL4P1,9) pH Monitoring Probe (PH2C10CM) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD10CMUU) Electrolytic Gel for pHmetry and ZpH (ACAL122) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD15CMUU) pH Monitoring Probe (PH2C13CM) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (IG2PH6Z16CMRE) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z16CMRE) ZpH Catheter ImpedancepHmetry Esophageal (IG2PH6Z14CMUU) ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z22CMUU) pH Monitoring Probe (PH2C18CM) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (IG2PH6Z20CMRE) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z10CMPDRE) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z14CMRE) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD11CMUU) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (2PH15_6Z15CMRE) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z12CMRE) AL-4 Catheter pHmetry Esophageal - External Reference (3PHAL4AD1324UU) AL-4 Catheter pHmetry Esophageal - External Reference (4PHAL4A51015UU) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD23cm) AL-4 Catheter pHmetry Esophageal - External Reference (3PHAL4AD723UU) ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z12CMUU) pH Monitoring Probe (PH2C15CM ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z18CMUU) pH Monitoring Probe (PH3C-15-19CM) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD13cm) pH 7 Buffer Solution ZpH Catheter ImpedancepHmetry Esophageal (IG2PH6Z20CMUU) pH Monitoring Probe (PH3C-15-20CM) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD21cm) AL-4 Catheter pHmetry Esophageal - External Reference (4PHAL4A101520UU) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD11cm) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD10cm) AL-4 Catheter pHmetry Esophageal (1CpHAL4AD1,4) pH Monitoring Probe (PH2C12CM) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD20CMUU) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z18CMRE) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD12CMUU) pH Monitoring Probe (PH1CAD) AL-4 Catheter pHmetry Esophageal (4CpHAL4AD51520cm) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD8CMUU) AL-4 Catheter pHmetry Esophageal (1CpHAL4P1,4) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD5CMUU) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD7cm) ZpH Catheter ImpedancepHmetry Esophageal (2PH18_6Z18CMUU) pH Monitoring Probe (PH2C21CM) AL-4 Catheter pHmetry Esophageal - External Reference (1PHAL4ADUU) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD13CMUU) pH Monitoring Probe (PH3C-15-18CM) AL-4 Equipment for Impedance-pHmetry Esophageal (AL-4 pH; AL-4 ZpH) AL-4 Catheter pHmetry Esophageal (4CpHAL4AD101521) pH Monitoring Probe (PH2C8CM) pH Monitoring Probe (PH2C20CM) ZpH Catheter ImpedancepHmetry Esophageal (2PH15_6Z15CMUU) AL-4 Catheter pHmetry Esophageal (3CpHAL4AD15-19cm) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD18cm) ZpH Catheter ImpedancepHmetry Esophageal (IG2PH6Z18CMUU) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z7CMPDRE) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD23CMUU) AL-4 Catheter pHmetry Esophageal - External Reference (4PHAL4A101821UU) pH 1 Buffer Solution AL-4 Catheter pHmetry Esophageal (3CpHAL4AD15-18cm) AL-4 Catheter pHmetry Esophageal - External Reference (3PHAL4AD1518UU) pH Monitoring Probe (PH1C-PED1,4) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (IG2PH6Z18CMRE) ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z14CMUU) ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z16CMUU ) BP-1 Urodynamics Infusion Pump - Peristaltic Pump PVC Rectal Balloon Probe (SDBL10PVC42; SDBL12PVC42; SDBL10PVC124; SDBL12PVC124) Silicone Tube for Infusion Mechanisms (DUCTUB001) UROCOMMANDER Equipment with EMG Biofeedback Balloon Probe (SB-BIO) Double Lumen Pig Tail Probe (4.1860B; SDL-PG-6FR; SDL-PG-7FR; SDL-PG-8FR) Connector for Minimally Invasive Male Urodynamics (DUAUMI) Infusion Set for Urodynamics Infusion Pump (EQUIPOBP1) UROCOMMANDER Equipment for Flowmetry UROCOMMANDER Equipment for Urodynamics Urodynamics Catheter Extender (EXTUR10FR120) Rectal Balloon Probe (B08FR-4; B10FR-4; B12FR-4) Double Lumen Probe (DL6FR; DL6FR-2F; DL6FR-30; DL7FR; DLFR8) UROCOMMANDER Equipment for Flowmetry Uroflow UROCOMMANDER Equipment for Biofeedback CFE-P-26C4.3-0.5; CFE-P-26C4.3-0.7; CFE-P-26C4.7-0.5; CFE-P-26C4.7-0.7; CFE-P-28C3.2-0.5; CFE-P-28C3.2-0.7; CFE-P-30C3.2-0.5; CFE-P-30C3.2-0.7; CFE-P-30C4.2-0.5; CFE-P-30C4.2-0.7; CFE-P-30C4.3-0.5; CFE-P-30C4.3-0.7; CFE-P-18C4.3-0.7-20cm; CFE-P-18C4.3-0.7-21cm; CFE-P-18C4.3-0.7-25cm; CFE-P-18C4.3-0.7-30cm; CFE-P-18C4.7-0.5-20cm; CFE-P-18C3.2-0.7-21cm; CFE-P-18C3.2-0.7-25cm; CFE-P-18C3.2-0.7-30cm; CFE-P-18C4.2-0.5-20cm; CFE-P-18C4.2-0.5-21cm; CFA-P-36C-4.7-6cm/RD2 CFA-P-12C-4.7-6cm/RD1; CFA-P-12C-4.7-6cm/SP1; CFA-P-14C-4.7-3cm; CFA-P-14C-4.7-4.5cm; CFA-P-14C-4.7-6cm; CFA-P-20C-4.7-6cm; CFA-P-22C-4.7-3cm; CFA-P-22C-4.7-4.5cm; CFA-P-22C-4.7-6cm; CFA-P-24V4; CFA-P-24V4.7; CFA-P-28C-4.7-6cm; CFA-P-30C-4.7-3cm; CFA-P-30C-4.7-4.5cm; CFA-P-30C-4.7-6cm; CFA-P-32C-4.7-3cm; Anorectal Easy Connect Catheters - 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36 Channels (CFA) CFE-P-30C4.7-0.5; CFE-P-30C4.7-0.7; CFE-P-32C3.2-0.5; CFE-P-32C3.2-0.7; CFE-P-32C4.2-0.5; CFE-P-32C4.2-0.7; CFA-P-24C-4.7-3cm; CFA-P-24C-4.7-4.5cm; CFA-P-24C-4.7-6cm; CFA-P-24C-4.7-6cm/RD1; CFA-P-24C-4.7-6cm/RD2; CFE-P-36C3.2-0.7-21cm; CFE-P-36C3.2-0.7-25cm; CFE-P-36C3.2-0.7-30cm; CFE-P-36C4.2-0.5-20cm; CFE-P-36C4.2-0.5-21cm; CFE-P-22C4.2-0.5; CFE-P-22C4.2-0.7; CFE-P-22C4.3-0.5; CFE-P-22C4.3-0.7; CFE-P-22C4.7-0.5; CFE-P-22C4.7-0.7; CFA-P-2C-4.7; CFA-P-2C-4; CFA-P-4C-4.7; CFA-P-4C-4; CFA-P-6C-4.7; CFA-P-6C-4; CFA-P-8C-4.7; CFA-P-8C-4; CFE-P-18C4.7-0.7-25cm; CFE-P-18C4.7-0.7-30cm; CFE-P-20C3.2-0.5; CFE-P-20C3.2-0.7; CFE-P-20C4.2-0.5; CFE-P-20C4.2-0.7; CFE-P-24C3.2-0.5-20cm; CFE-P-24C3.2-0.5-21cm; CFE-P-24C3.2-0.5-25cm; CFE-P-24C3.2-0.5-30cm; CFE-P-24C3.2-0.7-20cm; CFE-P-36C4.7-0.7-25cm; CFE-P-36C4.7-0.7-30cm CFE-P-18C4.2-0.7-30cm; CFE-P-18C4.3-0.5-20cm; CFE-P-18C4.3-0.5-21cm; CFE-P-18C4.3-0.5-25cm; CFE-P-18C4.3-0.5-30cm; CFE-P-12C3.2-0.5; CFE-P-12C3.2-0.7; CFE-P-12C4.2-0.5; CFE-P-12C4.2-0.7; CFE-P-12C4.3-0.5; CFE-P-12C4.3-0.7; CFA-P-10C-4.7; CFA-P-10C-4; CFA-P-12V4.7; CFA-P-12V4; CFA-P-12C-4.7-3cm; CFA-P-12C-4.7-4.5cm; Catheter Washer (LAVCAT-8CMU; LAVCAT-24CMU; LAVCAT-36CMU) CFE-P-14C4.3-0.5; CFE-P-14C4.3-0.7; CFE-P-14C4.7-0.5; CFE-P-14C4.7-0.7; CFE-P-16C3.2-0.5; CFE-P-16C3.2-0.7; CFE-P-24C4.2-0.7-30cm; CFE-P-24C4.3-0.5-20cm; CFE-P-24C4.3-0.5-21cm; CFE-P-24C4.3-0.5-25cm; CFE-P-24C4.3-0.5-30cm; CFE-P-24C3.2-0.7-21cm; CFE-P-24C3.2-0.7-25cm; CFE-P-24C3.2-0.7-30cm; CFE-P-24C4.2-0.5-20cm; CFE-P-24C4.2-0.5-21cm; CFE-P-16C4.2-0.5; CFE-P-16C4.2-0.7; CFE-P-16C4.3-0.5; CFE-P-16C4.3-0.7; CFE-P-16C4.7-0.5; CFE-P-16C4.7-0.7; CFA-P-36V4.7; CFA-P-36C-4.7-3cm; CFA-P-36C-4.7-4.5cm; CFA-P-36C-4.7-6cm; CFA-P-36C-4.7-6cm/RD1; CFE-P-36C4.2-0.7-30cm; CFE-P-36C4.3-0.5-20cm; CFE-P-36C4.3-0.5-21cm; CFE-P-36C4.3-0.5-25cm; CFE-P-36C4.3-0.5-30cm; CFE-P-32C4.3-0.5; CFE-P-32C4.3-0.7; CFE-P-32C4.7-0.5; CFE-P-32C4.7-0.7; CFE-P-34C3.2-0.5; CFE-P-34C3.2-0.7; Esophageal Easy Connect Catheters - 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36 (CFE) CFE-P-2C4.7-0.7; CFE-P-4C3.2-0.5; CFE-P-4C3.2-0.7; CFE-P-4C4.2-0.5; CFE-P-4C4.2-0.7; CFE-P-4C4.3-0.5; CFE-P-4C4.3-0.7; CFE-P-24C4.2-0.5-25cm; CFE-P-24C4.2-0.5-30cm; CFE-P-24C4.2-0.7-20cm; CFE-P-24C4.2-0.7-21cm; CFE-P-24C4.2-0.7-25cm; CFE-P-36C4.2-0.5-25cm; CFE-P-36C4.2-0.5-30cm; CFE-P-36C4.2-0.7-20cm; CFE-P-36C4.2-0.7-21cm; CFE-P-36C4.2-0.7-25cm; CFE-P-2C3.2-0.5; CFE-P-2C3.2-0.7; CFE-P-2C4.2-0.5; CFE-P-2C4.2-0.7; CFE-P-2C4.3-0.5; CFE-P-2C4.3-0.7; CFE-P-2C4.7-0.5; CFE-P-36C4.7-0.5-21cm; CFE-P-36C4.7-0.5-25cm; CFE-P-36C4.7-0.5-30cm; CFE-P-36C4.7-0.7-20cm; CFE-P-36C4.7-0.7-21cm; CFE-P-18C3.2-0.5-20cm; CFE-P-18C3.2-0.5-21cm; CFE-P-18C3.2-0.5-25cm; CFE-P-18C3.2-0.5-30cm; CFE-P-18C3.2-0.7-20cm; CFE-P-12C4.7-0.5; CFE-P-12C4.7-0.7; CFE-P-14C3.2-0.5; CFE-P-14C3.2-0.7; CFE-P-14C4.2-0.5; CFE-P-14C4.2-0.7; CFE-P-10C4.2-0.5; CFE-P-10C4.2-0.7; CFE-P-10C4.3-0.5; CFE-P-10C4.3-0.7; CFE-P-10C4.7-0.5; CFE-P-10C4.7-0.7; CFE-P-28C4.2-0.5; CFE-P-28C4.2-0.7; CFE-P-28C4.3-0.5; CFE-P-28C4.3-0.7; CFE-P-28C4.7-0.5; CFE-P-28C4.7-0.7; CFE-P-4C4.7-0.5; CFE-P-4C4.7-0.7; CFE-P-6C3.2-0.5; CFE-P-6C3.2-0.7; CFE-P-6C4.2-0.5; CFE-P-6C4.2-0.7; CFE-P-6C4.3-0.5; CFE-P-20C4.3-0.5; CFE-P-20C4.3-0.7; CFE-P-20C4.7-0.5; CFE-P-20C4.7-0.7; CFE-P-22C3.2-0.5; CFE-P-22C3.2-0.7; CFA-P-26C-4.7-3cm; CFA-P-26C-4.7-4.5cm; CFA-P-26C-4.7-6cm; CFA-P-28C-4.7-3cm; CFA-P-28C-4.7-4.5cm; CFE-P-36C3.2-0.5-20cm; CFE-P-36C3.2-0.5-21cm; CFE-P-36C3.2-0.5-25cm; CFE-P-36C3.2-0.5-30cm; CFE-P-36C3.2-0.7-20cm; CFA-P-18C-4.7-6cm/RD1; CFA-P-18C-4.7-6cm/RD2; CFA-P-18C-4.7-6cm/SP1; CFA-P-20C-4.7-3cm; CFA-P-20C-4.7-4.5cm; CFE-P-8C4.3-0.5; CFE-P-8C4.3-0.7; CFE-P-8C4.7-0.5; CFE-P-8C4.7-0.7; CFE-P-10C3.2-0.5; CFE-P-10C3.2-0.7; CFE-P-6C4.3-0.7; CFE-P-6C4.7-0.5; CFE-P-6C4.7-0.7; CFE-P-8C3.2-0.5; CFE-P-8C3.2-0.7; CFE-P-8C4.2-0.5; CFE-P-8C4.2-0.7; Single Connector Multiway (CUM8V; CUM12V; CUM24V; CUM36V; TP1; TP2) CFE-P-34C4.2-0.5; CFE-P-34C4.2-0.7; CFE-P-34C4.3-0.5; CFE-P-34C4.3-0.7; CFE-P-34C4.7-0.5; CFE-P-34C4.7-0.7; CFE-P-36C4.3-0.7-20cm; CFE-P-36C4.3-0.7-21cm; CFE-P-36C4.3-0.7-25cm; CFE-P-36C4.3-0.7-30cm; CFE-P-36C4.7-0.5-20cm; CFA-P-32C-4.7-4.5cm; CFA-P-32C-4.7-6cm; CFA-P-34C-4.7-3cm; CFA-P-34C-4.7-4.5cm; CFA-P-34C-4.7-6cm; CFA-P-36V4; CFE-P-24C4.3-0.7-20cm; CFE-P-24C4.3-0.7-21cm; CFE-P-24C4.3-0.7-25cm; CFE-P-24C4.3-0.7-30cm; CFE-P-24C4.7-0.5-20cm; CFA-P-16C-4.7-3cm; CFA-P-16C-4.7-4.5cm; CFA-P-16C-4.7-6cm; CFA-P-18C-4.7-3cm; CFA-P-18C-4.7-4.5cm; CFE-P-18C4.2-0.5-25cm; CFE-P-18C4.2-0.5-30cm; CFE-P-18C4.2-0.7-20cm; CFE-P-18C4.2-0.7-21cm; CFE-P-18C4.2-0.7-25cm; CFE-P-24C4.7-0.5-21cm; CFE-P-24C4.7-0.5-25cm; CFE-P-24C4.7-0.5-30cm; CFE-P-24C4.7-0.7-20cm; CFE-P-24C4.7-0.7-21cm; CFE-P-18C4.7-0.5-21cm; CFE-P-18C4.7-0.5-25cm; CFE-P-18C4.7-0.5-30cm; CFE-P-18C4.7-0.7-20cm; CFE-P-18C4.7-0.7-21cm; CFE-P-24C4.7-0.7-25cm; CFE-P-24C4.7-0.7-30cm; CFE-P-26C3.2-0.5; CFE-P-26C3.2-0.7; CFE-P-26C4.2-0.5; CFE-P-26C4.2-0.7;

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFT	Electrode, Ph, Stomach	Gastroenterology, Urology	Class 1	876.1400	2022-12-16
FEN	Device, Cystometric, Hydraulic	Gastroenterology, Urology	Class 2	876.1620	2024-01-12
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2022-11-29

Official Correspondent

Iracele Alkimim Sanches

US Agent Details

Juan Caballero Business: Grupo Red International Corporation Email: jscaballero@redconsultingus.com Phone: (786) 7173600

Related Public Records

Same Entity

ALACER INDUSTRIA ELETRONICA LTDA

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K883960	Vascular Technology Incorporated	GIPHY MONITOR	1989-10-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016854619. Last updated year: 2026. Please use registration number 3016854619 when referencing this establishment in official correspondence.