SPECULAR MICROSCOPE

GUDID 04987669100530

The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape

NIDEK CO.,LTD.

Optical pachymeter

• Primary Device ID: 04987669100530
• NIH Device Record Key: a25178a7-e538-460d-85bf-7a9ac62f5b91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPECULAR MICROSCOPE
• Version Model Number: CEM-530
• Company DUNS: 690635461
• Company Name: NIDEK CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-223-9044
• Email: info@nidek.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987669100530 [Primary]

FDA Product Code

• NQE: Microscope, Specular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-26

Devices Manufactured by NIDEK CO.,LTD.

• 04987669200018 - A-scan probe: 2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the OPTICAL BIOMETER AL-Scan.
• 04987669200049 - Pachymetry probe (45° fixed type): 2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the OPTICAL BIOMETER AL-Scan.
• 04987669200070 - A-scan probe: 2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.
• 04987669200094 - Pachymetry probe: 2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.
• 04987669200100 - Pachymetry probe (45° fixed type): 2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.
• 04987669200117 - A-scan probe: 2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the ECHOSCAN US-500.
• 04987669200780 - IOL-Station: 2023-07-18 The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optica
• 04987669100844 - IOL-Station: 2023-06-20 The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optica