Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008252907

FEI Number

3008252907

Entity Name

Simba Apparel EPZ LTD

City/State/Country

Mombasa, KE

Establishment Address

Changamwe, Refinery Road, Mombasa 99999, KE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Simba Apparel EPZ, Ltd. (Owner Number: 10050829)

Owner / Operator Contact Address

PO BOX 81579, Refinery Road, Changamwe, Mombasa, KE-28 80100, KE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

STANDARD TEXTILE STANDARD TEXTILE STANDARD TEXTILE STANDARD TEXTILE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FME	Gown, Examination	General Hospital	Class 1	880.6265	2015-12-31
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-05-26
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-08
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-05-29

Official Correspondent

Monica Neumann

US Agent Details

Monica Neumann Business: Shah Safari Inc. Email: quest@shahsafari.com Phone: (206) 3369426

Related Public Records

Same Entity

Simba Apparel EPZ, Ltd.

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
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

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1000358138	SHAH SAFARI	Seattle, WA, US
3011276959	PATIENTSTYLE MEDICAL LLC	San Leandro, CA, US
3014683120	JMU DENTAL, INC	Fullerton, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008252907. Last updated year: 2026. Please use registration number 3008252907 when referencing this establishment in official correspondence.