Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004083336

FEI Number

3004083336

Entity Name

MACROLAB ASOCIADOS S.A.S.

City/State/Country

MEDELLIN Antioquia, CO

Establishment Address

CARRERA 48 N 48 SUR 75 LOCAL, 152 ENVIGADO, MEDELLIN Antioquia C078, CO

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Macrolab Asociados S.A.S. (Owner Number: 9057003)

Owner / Operator Contact Address

CARRERA 48 N 48 SUR 75 LOCAL 152, ENVIGADO, CO-ANT 055420, CO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ecodent Mint * 100 yard Ecodent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JES	Floss, Dental	Dental	Class 1	872.6390	2003-06-19
NXZ	Dental Hygiene Kit	Dental	Class 1	872.6855	2015-12-30

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Macrolab Asociados S.A.S.

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
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004083336. Last updated year: 2026. Please use registration number 3004083336 when referencing this establishment in official correspondence.