Cofoe Za-01

by Cofoe Medical 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number06950715500002 UDI-DI	Date10 Jan 2022Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Cofoe
Generic Name: Air-conduction hearing aid, behind-the-ear
Model / Reference: ZA-01

Primary DI / UDI-DI: 06950715500002
FDA Product Code: QUF
GMDN Term: Air-conduction hearing aid, behind-the-ear

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

MRI Safety: MR Conditional

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Class IIa
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Class C
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Class C

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Properties

Over-the-Counter
Premarket Exempt
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (9)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Prescription Use: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No