Linkgold Medical Instrument Co Ltd

⚠️ Moderate Risk

FEI: 3008940759 • Shanghai • CHINA

FEI

FEI Number

3008940759

📍

Location

Shanghai

🇨🇳

Country

CHINA

🏢

Address

26 Changkang Road, Baoshan District, , Shanghai, , China

Moderate Risk

FDA Import Risk Assessment

37.7

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

6/10/2011

Latest Refusal

6/10/2011

Earliest Refusal

Score Breakdown

Violation Severity

30.0×40%

Refusal Volume

52.4×30%

Recency

0.0×20%

Frequency

100.0×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

34125×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

Date	Product	Violations	Division
6/10/2011	76EHYTRAY, IMPRESSION, PREFORMED	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76DYNMOUTHPIECE, SALIVA EJECTOR	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76DYNMOUTHPIECE, SALIVA EJECTOR	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76DYNMOUTHPIECE, SALIVA EJECTOR	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76EFWTOOTHBRUSH, MANUAL	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76EIFACCESSORIES, RETRACTOR, DENTAL	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76EIFACCESSORIES, RETRACTOR, DENTAL	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76EHYTRAY, IMPRESSION, PREFORMED	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	79FXXMASK, SURGICAL	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76EAXMIRROR, MOUTH	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76EGNSCISSORS, SURGICAL TISSUE, DENTAL	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76EKBEXPLORER, OPERATIVE	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76EMNSCALER, PERIODONTIC	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76EIXPROBE, PERIODONTIC	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76EATTESTER, PULP	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76ELCSCALER, ULTRASONIC	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76NRDUNIT, OPERATIVE DENTAL, ACCESSORIES	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76KLCCHAIR WITH UNIT	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76KLCCHAIR WITH UNIT	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76EFNCOTTON, ROLL	341REGISTERED	Baltimore District Office (BLT-DO)
6/10/2011	76EHDUNIT, X-RAY, EXTRAORAL WITH TIMER	341REGISTERED	Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is Linkgold Medical Instrument Co Ltd's FDA import refusal history?

Linkgold Medical Instrument Co Ltd (FEI: 3008940759) has 25 FDA import refusal record(s) in our database, spanning from 6/10/2011 to 6/10/2011.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Linkgold Medical Instrument Co Ltd's FEI number is 3008940759.

What types of violations has Linkgold Medical Instrument Co Ltd received?

Linkgold Medical Instrument Co Ltd has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Linkgold Medical Instrument Co Ltd come from?

All FDA import refusal data for Linkgold Medical Instrument Co Ltd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.