Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016603542

FEI Number

3016603542

Entity Name

Sion Biotext Mexico, S.A.P.I. de C.V

City/State/Country

Jiutepec Morelos, MX

Establishment Address

Street 13 este No 585 Civac, Jiutepec Morelos 62578, MX

Establishment Type(s)

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

Owner / Operator

SION BIOTEXT MEDICAL LTD (Owner Number: 8030128)

Owner / Operator Contact Address

3 Eshel St, Sapirim Industrial Park, Sderot, IL-NOTA 8701002, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2020-10-05
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2009-05-04
JXL	Block, Bite	Neurology	Class 2	882.5070	2024-05-13
EFN	Cotton, Roll	Dental	Class 1	872.6050	2024-04-03
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2024-08-29
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-01-29
KOY	Degreaser, Skin, Surgical	General, Plastic Surgery	Class 1	878.4730	2010-10-27

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc. Email: info@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

SION BIOTEXT MEDICAL LTD

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8030128	SION BIOTEXT MEDICAL LTD	Sderot Southern, IL

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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3017896419	FESUN SHANGHAI CO., LTD.	shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016603542. Last updated year: 2026. Please use registration number 3016603542 when referencing this establishment in official correspondence.