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Saturnus Medical Limited

⚠️ Moderate Risk

FEI: 3003693172 • Road Town • BRITISH VIRGIN ISLANDS

FEI

FEI Number

3003693172

📍

Location

Road Town

🇻🇬
🏢

Address

P.O. Box 146, , Road Town, , British Virgin Islands

Moderate Risk

FDA Import Risk Assessment

35.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
2
Unique Violations
6/25/2004
Latest Refusal
6/25/2004
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

3416×

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).

5086×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
6/25/2004
78GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
6/25/2004
79GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
6/25/2004
79GAQSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
6/25/2004
79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
6/25/2004
87HRXARTHROSCOPE AND ACCESSORIES
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
6/25/2004
85HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Saturnus Medical Limited's FDA import refusal history?

Saturnus Medical Limited (FEI: 3003693172) has 6 FDA import refusal record(s) in our database, spanning from 6/25/2004 to 6/25/2004.

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. Saturnus Medical Limited's FEI number is 3003693172.

What types of violations has Saturnus Medical Limited received?

Saturnus Medical Limited has been cited for 2 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 Saturnus Medical Limited come from?

All FDA import refusal data for Saturnus Medical Limited 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.