HARIOMED

Basic Information

• Brand Name: HARIOMED
• Primary DI: 06975183900116
• Version / Model: IW-A1800S
• Company Name: Hua Yue Medical Technology Co., Ltd.
• Labeler DUNS: 625413598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-14
• Public Version: 1
• Public Version Date: 2025-03-24
• Public Version Status: New
• Public Device Record Key: cae3ff2a-f14f-417b-8531-37b57441773d

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QKH	Assisted Reproduction Laminar Flow Workstation	Obstetrics/Gynecology	884.6120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
20653	Class-II biological safety cabinet	A furniture-like device designed as a partial or total enclosure to provide a class II biosafety level (BSL) to the operator, the product, and the environment during the manipulation of microorganisms and other biological hazardous materials (usually up to category 3 pathogens). It typically utilizes laminar airflow (LAF), a high-efficiency particulate air (HEPA) filter, and/or carbon filter and hydrogen peroxide (H2O2) gas as some of the protective mechanisms. It is used for handling cell cultures and human pathogens (e.g., bacteria, viruses, parasites) and other biohazardous materials, extremely toxic agents (e.g., chemotherapy drugs), and also for tissue culture and tumour virus work.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06975183900116	GS1