Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615834

FEI Number

3003080016

Entity Name

AGAPLASTIC IND. COM. LTDA.

City/State/Country

RIO DE JANEIRO, BR

Establishment Address

RUA CUBA NO 353, RIO DE JANEIRO 21020-160, BR

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

AGAPLASTIC IND. COM. LTDA. (Owner Number: 9040469)

Owner / Operator Contact Address

RUA CUBA NO 353, Penha, RIO DE JANEIRO-RJ, BR-RJ 21020-160, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TIC-TONG FLAVORED TONGUE DEPRESSOR TIC-TONG FLAVORED TONGUE DEPRESSOR BIO Dalmatian Reflex Hammer AGACHAMBER SPACER AGACHAMBER SPACER EXTRA PEDIATRIC ROCKET DOSER NOSE WASH MAX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2000-02-22
GWZ	Percussor	Neurology	Class 1	882.1700	2016-01-25
KCO	Nasal Spray, Ent Delivery	Ear, Nose, Throat	Class 1	874.5220	2007-02-21
NVP	Holding Chambers, Direct Patient Interface	Anesthesiology	Class 2	868.5630	2011-10-27
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2000-06-27
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2023-07-12

Official Correspondent

TEREZA CRISTINA DE OLIVEIRA REIS

US Agent Details

Alan Schwartz Business: MDI CONSULTANTS, INC. Email: INFO@MDICONSULTANTS.COM Phone: (516) 4829001

Related Public Records

Same Entity

AGAPLASTIC IND. COM. LTDA.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3013298431	VEENAK INTERNATIONAL LIMITED	BIRMINGHAM, GB
3023917	ACME UNITED CORP.	VANCOUVER, WA, US
3010420046	CITOTEST Labware Manufacturing CO., LTD.	Haimen Jiangsu, CN
3004608878	INTEGRA LIFESCIENCES CORPORATION	CINCINNATI, OH, US
3010155661	Synergy Health Sterilisation UK Ltd	Thorne Doncaster, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615834. Last updated year: 2026. Please use registration number 9615834 when referencing this establishment in official correspondence.