Sino-K SC1511

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

in data synced 22 Oct 2026

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	Number06972820967518 UDI-DI	Date5 Sep 2023Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Sino-K
Generic Name: Blood pressure cuff, reusable
Model / Reference: SC1511

Primary DI / UDI-DI: 06972820967518
510(k) Number: K231961
FDA Product Code: DXQ
GMDN Term: Blood pressure cuff, reusable

Device Class: Class II
Regulation Number: 870.1120
GUDID distribution status: In Commercial Distribution

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Properties

Prescription Use
Lot / Batch Number
Expiration Date
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
Premarket Exempt: No
Serial Number: No