zumax

FDA UDI

Class I (US FDA UDI)

by Zumax Medical Co., LTD

Identity

Trade Name: zumax FDA UDI
Generic Name: Retinoscope, battery-powered FDA UDI
Device Name: Streak Retinoscope bulb,3.5V FDA UDI
Model / Reference: R4180 FDA UDI
Description: Streak Retinoscope bulb,3.5V FDA UDI

Identifiers

Primary DI / UDI-DI: 06945095531999 FDA UDI
FDA Product Code: HKM FDA UDI
GMDN Term: Retinoscope, battery-powered FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.1780 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Retinoscope, battery-powered

zumax by Zumax Medical Co., LTD — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Zumax Medical Co., LTD

Sources (1)

FDA UDI 328ecb11-7a3d-479b-b464-45d9a8d6ffd8 33 fields · synced May 30, 2026