EB-2000xyz

GUDID 00852194002021

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.

Hightech American Industrial Labs Inc

Ophthalmic specular microscope

• Primary Device ID: 00852194002021
• NIH Device Record Key: eaff279d-748d-4d53-b99c-b936f3bf8bbf
• Commercial Distribution Discontinuation: 2025-12-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: EB-2000xyz
• Version Model Number: 1
• Company DUNS: 961991916
• Company Name: Hightech American Industrial Labs Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852194002021 [Primary]

FDA Product Code

• NQE: Microscope, Specular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-02
• Device Publish Date: 2025-12-25

Devices Manufactured by Hightech American Industrial Labs Inc

• 00852194002007 - EB-3000xyz: 2026-01-02 HAI EB-3000xyz is the non-contact eyebank specular microscope which is used to evaluate the endothelial cells layer for human c
• 00852194002021 - EB-2000xyz: 2026-01-02HAI 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.
• 00852194002021 - EB-2000xyz: 2026-01-02 HAI EB-2000xyz is the non-contact eyebank specular microscope which is to be used to evaluate the endothelial cells layer for la
• 00852194002090 - HAI Caliper: 2025-12-24 Caliper, surgical instrument for ophthalmic use
• 00852194002106 - HAI Trephine: 2025-12-24 Trephine, Surgical instrument for ophthalmic use
• 00852194002113 - HAI Specula: 2025-12-24 Specula, Surgical instrument for ophthalmic use
• 00852194002120 - HAI Spoon: 2025-12-24 Spoon, Surgical instrument for ophthalmic use
• 00852194002144 - HAI Spatula: 2025-12-24 Spatula, Surgical instrument for ophthalmic use
• 00852194002045 - HAI Scissisors: 2025-12-23 Scissors, surgical instruments for ophthalmic use