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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Zoomax Luna EYE; Zoomax Luna HD 24 Pro; Zoomax Snow Eye
Classification Name: SPECTACLE, MAGNIFYING
Product Code: HOI
Device Class: 1
Regulation Number: 886.5840
Medical Specialty: Ophthalmic
Registered Establishment Name: ZOOMAX TECHNOLOGY CO., LIMITED
Registered Establishment Number: 3014656175
Owner/Operator: ZOOMAX TECHNOLOGY CO., LIMITED
Owner/Operator Number: 10058836
Establishment Operations: Contract Manufacturer; Contract Sterilizer; Foreign Exporter; Remanufacturer; Repackager/Relabeler; Reprocessor of Single Use Devices; Complaint File Establishment; Foreign Private Label Distributor
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