Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007163376

FEI Number

3007163376

Entity Name

HUONS CO., LTD.

City/State/Country

Jecheon-si Chungbuk, KR

Establishment Address

100, Bio Valley-ro, Jecheon-si Chungbuk 27159, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HUONS CO., LTD. (Owner Number: 10026948)

Owner / Operator Contact Address

1 Broadway CIC, 14F, Cambridge, MA 02142, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sodium Chloride Inj. 0.9% USP 5mL and 10mL Ampule

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2011-08-11

Official Correspondent

No official correspondent registered.

US Agent Details

Kathy Dassler Business: SPECTRA MEDICAL DEVICES LLC Email: kdassler@spectramedical.com Phone: (978) 6570889

Related Public Records

Same Entity

HUONS CO., LTD.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2011	Excelsior Medical Corp	2	Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use
Z-0044-2007	Excelsior Medical Corp	2	0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex.

Similar Registrations

Registration Number	Establishment Name	Location
3043709866	HANTECH (NINGBO) MEDICAL TECHNOLOGY CO., LTD.	Ningbo Zhejiang, CN
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US
3014421917	O&M Halyard, Inc.	Alpharetta, GA, US
3016413378	JIAXING TIANHE PHARMACEUTICAL CO., LTD.	Jiaxing Zhejiang, CN
3005934752	MEDXL INC	Pointe-Claire Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007163376. Last updated year: 2026. Please use registration number 3007163376 when referencing this establishment in official correspondence.