Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022954003

FEI Number

3022954003

Entity Name

BIOANA

City/State/Country

Monterrey Nuevo Leon, MX

Establishment Address

Angel Martinez Villarreal 510, Colonia Chepevera, Monterrey Nuevo Leon 64030, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Bioana (Owner Number: 10085975)

Owner / Operator Contact Address

Angel Martinez Villarreal 510, Colonia Chepevera, Monterrey, MX-NLE 64030, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2023-10-11
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2024-12-19
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2022-10-06

Official Correspondent

Andrea Siller

US Agent Details

Josue Garza Bedolla Business: IPS Consulting LLC Email: jgarza@insumosparasalud.com Phone: (312) 7720241

Related Public Records

Same Entity

Bioana

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
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Similar Registrations

Registration Number	Establishment Name	Location
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3012170108	JET TECH EUROPE S.R.L.	Milan Milano, IT
3005450640	EUNSUNG GLOBAL CORP.	Wonju-si Gangwon, KR
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3029972466	ASTERASYS CO., LTD.	Seongdong-gu Seoul, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022954003. Last updated year: 2026. Please use registration number 3022954003 when referencing this establishment in official correspondence.