EB-2000xyz

Basic Information

• Brand Name: EB-2000xyz
• Primary DI: 00852194002021
• Version / Model: 1
• Company Name: Hightech American Industrial Labs Inc
• Labeler DUNS: 961991916
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-25
• Public Version: 1
• Public Version Date: 2026-01-02
• Public Version Status: New
• Public Device Record Key: eaff279d-748d-4d53-b99c-b936f3bf8bbf
• Distribution End Date: 2025-12-25

Device Description

HAI EB-2000xyz is the non-contact eyebank specular microscope which is to be used to evaluate the endothelial cells layer for layer for both human and animal cornea. HAI EB-2000xyz used the same design as the Bio-Optic Inc. (An US manufacturer), it considered the device substantially equivalent to legally marketed predicate devices market predicate devices market in interstate commerce prior to May 28, 1976. That do not require approval of a premarket approval. According to the letter from FDA on April. 26, 2094.

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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NQE	Microscope, Specular	Ophthalmic	886.1850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66212	Ophthalmic specular microscope	An electrically-powered, ophthalmic, binocular microscope designed for in vivo examination of the inner cellular lining of the cornea (endothelium), and to capture and analyse endothelial cell images, typically to assist with the diagnosis of various corneal disorders (e.g., corneal dystrophies, degenerative diseases, pre- and post-operative assessment). It is typically a desk-top unit with a patient head rest and dedicated software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852194002021	GS1