AXIO BIOSOLUTIONS PVT LTD

FDA Device Registration & Listing · Ahmedabad Gujarat, IN · Registration 3015525200

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
3015525200
FEI Number
3015525200
Entity Name
AXIO BIOSOLUTIONS PVT LTD
City/State/Country
Ahmedabad Gujarat, IN
Establishment Address
Plot 18, Gujarat Pharma Techno Park, Sari Matoda, Sanand Taluka, Ahmedabad Gujarat 382220, IN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
AXIO BIOSOLUTIONS PVT LTD (Owner Number: 10060640)
Owner / Operator Contact Address
Plot 18, Gujarat Pharma Techno Park, Sari Matoda, Sanand Taluka, Ahmedabad, IN-GJ 382220, IN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Axiostat Gauze Ax-Surgi Surgical Hemostat Maxiocel Chitosan Wound Dressing Axiostat Patch

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2023-05-08
POD Temporary, Internal Use Hemostatic General, Plastic Surgery Class 2 878.4454 2023-05-08
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2024-02-09
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2021-06-18

Official Correspondent

Gourav Maheshwari

US Agent Details

Alan Donald Business: Matrix Medical Consulting, Inc. Email: adonald@me.com Phone: (619) 2085624

Related Public Records

Same Entity

AXIO BIOSOLUTIONS PVT 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
K220566 Koag, LLC Vascette HP (hemostatic pad) 2022-07-29
K080818 Hem Con Medical Technologies, Inc. HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING 2008-05-15
K893123 Les Laboratorires Brothier, S.A. ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES 1990-02-13
K143462 Benq Materials Corporation AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) 2015-05-08
K040208 Tz Medical, Inc. NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND 2004-05-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015525200. Last updated year: 2026. Please use registration number 3015525200 when referencing this establishment in official correspondence.
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