Na 118

by wenzhou dongfang medical instrument 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	Number06970784670178 UDI-DI	Date20 Aug 2024Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Mechanical external stethoscope
Model / Ref / Catalog: 118, KT-118

Primary DI / UDI-DI: 06970784670178
FDA Product Code: LDE
GMDN Term: Mechanical external stethoscope

Device Class: Class I
Regulation Number: 870.1875
GUDID distribution status: In Commercial Distribution

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Properties

Premarket Exempt
Lot / Batch Number
Expiration Date

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No
Manufacturing Date: No