Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020623413

FEI Number

3020623413

Entity Name

NITTA S.A.

City/State/Country

Bogota, CO

Establishment Address

Carrera 21 # 166-57, Zona Industrial Toberin, Bogota 110131, CO

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NITTA S.A. (Owner Number: 10086882)

Owner / Operator Contact Address

Carrera 21 # 166-57, Zona Industrial Toberin, Bogota, CO-DC 110131, CO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NITTA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-12-19

Official Correspondent

Maria Vargas

US Agent Details

Maria Vargas Business: NITTA LLC Email: exec.office@nitta.com.co Phone: (773) 2494320

Related Public Records

Same Entity

NITTA S.A.

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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020623413. Last updated year: 2026. Please use registration number 3020623413 when referencing this establishment in official correspondence.