Zepp Clarity Open Dome S

GUDID 00850051482948

Anhui Huami Information Technology Co., Ltd.

Air-conduction hearing aid, canal
Primary Device ID00850051482948
NIH Device Record Key192f22d8-6b79-4e67-860c-0f80891bc6b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameZepp Clarity Open Dome S
Version Model NumberA2317Y
Company DUNS421368652
Company NameAnhui Huami Information Technology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850051482948 [Primary]

FDA Product Code

QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-06
Device Publish Date2023-11-28

Devices Manufactured by Anhui Huami Information Technology Co., Ltd.

00850051482931 - Zepp Clarity Tulip Dome 2023-12-06
00850051482948 - Zepp Clarity Open Dome S2023-12-06
00850051482948 - Zepp Clarity Open Dome S2023-12-06
00850051482955 - Zepp Clarity Open Dome M2023-12-06
00850051482962 - Zepp Clarity Open Dome L2023-12-06
00850051482979 - Zepp Clarity Closed Dome S2023-12-06
00850051482986 - Zepp Clarity Closed Dome M2023-12-06
00850051482993 - Zepp Clarity Closed Dome L2023-12-06
00850058994000 - Zepp Clarity Omni2023-12-06

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