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

FDA Device Registration & Listing · Civac Mexico, MX · Registration 3035479692

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3035479692
FEI Number
3035479692
Entity Name
Sion Biotext Mexico, S.A.P.I. De C.V.,
City/State/Country
Civac Mexico, MX
Establishment Address
Avenida Centenario, No. 5, Esquina Andador 11 Este y 56 Sur, Lote 12 y 5 Manzana 1, Civac Mexico 62578, MX
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
Sion Biotext Mexico, S.A.P.I. De C.V. (Owner Number: 10092513)
Owner / Operator Contact Address
Avenida Centenario, No. 5, Esquina Andador 11 Este y 56 Sur, Lote 12 y 5 Manzana 1,, Civac, MX-MEX 62578, MX
Initial Importer Flag
N
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
NEC Bandage, Liquid, Skin Protectant General Hospital Class 1 880.5090 2025-03-06
EFN Cotton, Roll Dental Class 1 872.6050 2025-03-06
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2025-01-16
FQM Bandage, Elastic General Hospital Class 1 880.5075 2025-03-06
MNK Endoscopic Bite Block Gastroenterology, Urology Class 1 876.1500 2025-03-06
FRO Dressing, Wound, Drug Unknown Class U N/A 2025-03-06
EAX Mirror, Mouth Dental Class 1 872.4565 2025-03-06
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2025-03-06

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 Mexico, S.A.P.I. De C.V.
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035479692. Last updated year: 2026. Please use registration number 3035479692 when referencing this establishment in official correspondence.
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