Sinolinks Medical Innovation, Inc.

ChangZhou Jiangsu, CN

Sinolinks Medical Innovation, Inc. appears in FDA device records in ChangZhou Jiangsu, CN. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 0
Registered establishments: 1

510(k) clearance history

FDA records hold 1 510(k) clearance for Sinolinks Medical Innovation, Inc. in 2025.

Clearances by year, as a table

510(k) clearance decisions for Sinolinks Medical Innovation, Inc., by decision year
Year	Clearances
2025	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K250820	Disposable Trocars	GCJ	Substantially Equivalent	2025-07-11

Registered establishments

FDA registered establishments for Sinolinks Medical Innovation, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3008383115	3008383115	Sinolinks Medical Innovation, Inc.	NO.10 Ziwei Road, Zhonglou Zone, ChangZhou Jiangsu 213032 CN	2026	GCJ GDO GDW KDC QQS

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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What MDM checks, and what it does not

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain