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AMSINO INTERNATIONAL, INC.

United States·US-MF-000007234

Last updated May 23, 2026

What AMSINO INTERNATIONAL, INC. makes

AMSINO International, Inc. manufactures single-use intravenous administration sets, suction and irrigation tubing, general-purpose vacuum suction systems, intravenous tubing extensions, non-sterile enteral feeding kits, indwelling urethral drainage catheters, nebulizing delivery sets, and airway suction catheters. Their portfolio includes surgical suction systems with digital controls, waste fluid management accessories, and specialized filters for smoke evacuation. The company also supplies reusable and disposable components for surgical and medical suction applications, as well as burette sets for fluid administration.

The company’s devices are classified under FDA’s Class I and Class II (including Class IIa) regulations and are listed in the FDA’s Unique Device Identifier (UDI) database and the EU’s eudamed registry. The products are designed for medical, surgical, and respiratory use, adhering to relevant regulatory standards for safety and performance in their respective categories.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
United States
Address
708 Corporate Center Drive, Pomona, United States
Website
amsino.com
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Paul Shen
EUDAMED SRN
US-MF-000007234
FDA FEI Number
—
DUNS Number
825673239

Catalogue (808)

Page 17 of 17
DeviceModel / ReferenceRegistriesClassStatus
Amsino I.v. Start Kit K050654
FDA 510(k)
Class IIActive
Amsure Pvc Intermittent Catheter K091306
FDA 510(k)
Class IIActive
Amsino Endotracheal Tube K050785
FDA 510(k)
Class IIActive
AMSafe Pre-Filled Normal Saline Flush Syringe K213522
FDA 510(k)
Class IIActive
AMSure Sterile Water, and Sterile Normal Saline for Wound Flush K181423
FDA 510(k)
UActive
Amsure Foley Catheter K030120
FDA 510(k)
Class IIActive
Amsino Tracheostomy Care Tray K023276
FDA 510(k)
Class IIActive
AMSure Hydrophilic Intermittent Catheter K181445
FDA 510(k)
Class IIActive
Amself Closed Catheterization System K082831
FDA 510(k)
Class IIActive
Amsino I.v. Administration And Extension Sets K101958
FDA 510(k)
Class IIActive
Amsure Hydrophilic Latex Foley Catheter K091699
EUDAMEDFDA 510(k)FDA UDI
Class IIActive

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