Magnifier

Basic Information

• Brand Name: Magnifier
• Primary DI: 06935740746595
• Version / Model: EX-06 ;1Pc/Box
• Company Name: Urit Medical Electronic Co., Ltd.
• Labeler DUNS: 653742429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-22
• Public Version: 1
• Public Version Date: 2025-09-30
• Public Version Status: New
• Public Device Record Key: d91d5ea9-eb48-47d1-929d-5be6eb5dc184

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• 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
HJF	Magnifier, Hand-Held, Low-Vision	Ophthalmic	886.5540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30045	Hand-held magnifier	A magnifying ophthalmic lens with a handle intended to enlarge text/images for a visually impaired patient/person. It is also known as a magnifying glass and can be made of solid plastic material or glass within a plastic or metal frame.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06935740746595	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius