Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004637474

FEI Number

3004637474

Entity Name

LABORATORIOS ZEPOL S.A.

City/State/Country

Curridabat San Jose, CR

Establishment Address

75 Mts Al Norte Del Servicentro, La Galera Carretera a Cipreses, Curridabat San Jose 3399-1000, CR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Laboratorios Zepol S.A. (Owner Number: 10055427)

Owner / Operator Contact Address

75 Mts Al Norte Del Servicentro, La Galera Carretera a Cipreses, Curridabat, CR-SJ 3399-1000, CR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K131176

PMA Number

N/A

All Registered Proprietary Names

Asclepii Poseidon Nanosilver Hydrogel Rx 3 oz Asclepii Poseidon Nanosilver Hydrogel Rx 1 oz Asclepii Poseidon Nanosilver Hydrogel OTC 3oz Asclepii Poseidon Nanosilver Hydrogel OTC 1oz

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2018-03-26
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2017-07-24

Official Correspondent

Heyner Rodriguez

US Agent Details

Aldo Martinez Business: ReguLab Union, LLC Email: control@regulab.us Phone: (956) 5099004

Related Public Records

Same Entity

Laboratorios Zepol 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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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3007128716	Medline Industries, LP	Norristown, PA, US
3012456427	UFP TECHNOLOGIES, INC.	Newburyport, MA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004637474. Last updated year: 2026. Please use registration number 3004637474 when referencing this establishment in official correspondence.