Mirasing - IncenSonic R20D1

by Xiamen Mirasing Technology Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number06975958550546 UDI-DI	Date13 Feb 2023Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Mirasing; IncenSonic
Generic Name: Air-conduction hearing aid, in-the-ear
Model / Reference: R20D1

Primary DI / UDI-DI: 06975958550546
FDA Product Code: QUF
GMDN Term: Air-conduction hearing aid, in-the-ear
Models / Variants: Mirasing
IncenSonic R20D1

Device Class: Class I
Regulation Number: 874.3300
GUDID distribution status: In Commercial Distribution

Other devices from Xiamen Mirasing Technology Co., Ltd.

Mirasing SA01

Class I
Mirasing SR02

Class I
Mirasing SE21

Class I
Mirasing SE41

Class I
Mirasing SE01

Class I
Mirasing SE61

Class I

See all devices from Xiamen Mirasing Technology Co., Ltd. →

Properties

Over-the-Counter
Premarket Exempt
Serial Number
Manufacturing Date

Other properties (10)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Prescription Use: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Lot / Batch Number: No
Expiration Date: No