Sino-K SG31XXP

by Shenzhen SINO-K 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	Number06972820963671 UDI-DI	Date17 Feb 2022Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Sino-K
Generic Name: Electrocardiographic lead set, reusable
Model / Reference: SG31XXP

Primary DI / UDI-DI: 06972820963671
FDA Product Code: IKD
GMDN Term: Electrocardiographic lead set, reusable

Device Class: Class II
Regulation Number: 890.1175
GUDID distribution status: In Commercial Distribution

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Properties

Prescription Use
Premarket Exempt
Lot / Batch Number
Manufacturing Date

Other properties (10)

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