CEPLAST MEDICAL DEVICES, LLC

FDA Device Registration & Listing · Miami, FL, US · Registration 3006411563

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006411563
FEI Number
3006411563
Entity Name
CEPLAST MEDICAL DEVICES, LLC
City/State/Country
Miami, FL, US
Establishment Address
201 S Biscayne Blvd Ste 1200, Miami, FL 33131, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
CEPLAST MEDICAL DEVICES, LLC (Owner Number: 9105600)
Owner / Operator Contact Address
201 S. Biscayne Blvd. Suite 1200, Miami, FL 33131, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K101348
PMA Number
N/A

All Registered Proprietary Names

Nose Wash Syringe Dispositivo para Lavagem Nasal Pequenos Cuidados NOSE WASH MAX Dalmatian Reflex Hammer ROCKET DOSER AGACHAMBER SPACER EXTRA

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KCP Syringe, Ent Ear, Nose, Throat Class 1 874.5220 2021-12-29
KAR Irrigator, Sinus Ear, Nose, Throat Class 1 874.4420 2023-07-12
GWZ Percussor Neurology Class 1 882.1700 2023-07-24
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2023-07-24
NVP Holding Chambers, Direct Patient Interface Anesthesiology Class 2 868.5630 2023-07-24

Official Correspondent

TEREZA REIS

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CEPLAST MEDICAL DEVICES, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006411563. Last updated year: 2026. Please use registration number 3006411563 when referencing this establishment in official correspondence.
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