Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3036757319

FEI Number

3036757319

Entity Name

MIRSA MANUFACTURA INSPECCION Y RETRABAJO

City/State/Country

REYNOSA Tamaulipas, MX

Establishment Address

PRIVADA MARTEL S/N LOTE 1 Y 2, PARQUE INDUSTRIAL REYNOSA SECCION NORTE, REYNOSA Tamaulipas 88788, MX

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

MIRSA MANUFACTURA INSPECCION Y RETRABAJO (Owner Number: 10092811)

Owner / Operator Contact Address

PRIVADA MARTEL S/N LOTE 1 Y 2, PARQUE INDUSTRIAL REYNOSA SECCION NORTE, REYNOSA, MX-TAM 88788, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121050

PMA Number

N/A

All Registered Proprietary Names

MicroWash

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EPN	Pump, Nebulizer, Manual	Ear, Nose, Throat	Class 1	874.5220	2025-02-20
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2025-02-20
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2025-02-20

Official Correspondent

Luis Herrera

US Agent Details

Kenneth Kleinhenz Business: QSR Consulting Email: kleinhenz64@gmail.com Phone: (619) 2449573

Related Public Records

Same Entity

MIRSA MANUFACTURA INSPECCION Y RETRABAJO

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2011	Excelsior Medical Corp	2	Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use
Z-0044-2007	Excelsior Medical Corp	2	0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036757319. Last updated year: 2026. Please use registration number 3036757319 when referencing this establishment in official correspondence.