Na Aps-Ber

by Chongqing Kanghua Ruiming S&T 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	Number06951214400084 UDI-DI	Date22 Mar 2018Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Ophthalmic fundus camera
Model / Reference: APS-BER

Primary DI / UDI-DI: 06951214400084
FDA Product Code: HKI
GMDN Term: Ophthalmic fundus camera

Device Class: Class II
Regulation Number: 886.1120
GUDID distribution status: In Commercial Distribution

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Properties

Prescription Use
Premarket Exempt
Serial Number
Expiration Date
Manufacturing Date

Other properties (9)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Lot / Batch Number: No