Shanghai Neo-Medical Import & Export Co., Ltd.

⚠️ High Risk

FEI: 3005327291 • Shanghai, Shanghai • CHINA

FEI

FEI Number

3005327291

📍

Location

Shanghai, Shanghai

🇨🇳

Country

CHINA

🏢

Address

B/D3 183 Room 2004, Huaihai West Rd, Shanghai, Shanghai, China

High Risk

FDA Import Risk Assessment

54.0

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

103

Total Refusals

Unique Violations

10/23/2009

Latest Refusal

11/1/2005

Earliest Refusal

Score Breakdown

Violation Severity

53.9×40%

Refusal Volume

74.7×30%

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

50888×

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.

34153×

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).

11841×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

Date	Product	Violations	Division
10/23/2009	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/23/2009	80GAZTUBING, NONINVASIVE	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/23/2009	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/23/2009	80BRZSET, BLOOD TRANSFUSION	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/23/2009	79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY	341REGISTERED	Florida District Office (FLA-DO)
10/23/2009	78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)	341REGISTERED	Florida District Office (FLA-DO)
10/23/2009	74DXQCUFF, BLOOD-PRESSURE	341REGISTERED	Florida District Office (FLA-DO)
10/23/2009	80FLKTHERMOMETER, CLINICAL MERCURY	341REGISTERED	Florida District Office (FLA-DO)
8/13/2009	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	508NO 510(K)	Florida District Office (FLA-DO)
8/13/2009	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	508NO 510(K)	Florida District Office (FLA-DO)
8/13/2009	80GAZTUBING, NONINVASIVE	508NO 510(K)	Florida District Office (FLA-DO)
8/13/2009	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Florida District Office (FLA-DO)
8/13/2009	79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY	508NO 510(K)	Florida District Office (FLA-DO)
8/13/2009	78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)	508NO 510(K)	Florida District Office (FLA-DO)
8/13/2009	74DXQCUFF, BLOOD-PRESSURE	508NO 510(K)	Florida District Office (FLA-DO)
8/13/2009	73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL	508NO 510(K)	Florida District Office (FLA-DO)
9/9/2008	79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY	341REGISTERED	Division of Southeast Imports (DSEI)
9/9/2008	85HDZKNIFE, CERVICAL CONE	341REGISTERED	Division of Southeast Imports (DSEI)
9/9/2008	80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING	341REGISTERED	Division of Southeast Imports (DSEI)
9/9/2008	78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)	341REGISTERED	Division of Southeast Imports (DSEI)
9/9/2008	80BRZSET, BLOOD TRANSFUSION	341REGISTERED	Division of Southeast Imports (DSEI)
9/9/2008	80KZDINFUSOR, PRESSURE, FOR I.V. BAGS	341REGISTERED	Division of Southeast Imports (DSEI)
8/23/2007	80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING	341REGISTERED	Division of Southeast Imports (DSEI)
8/23/2007	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	341REGISTERED	Division of Southeast Imports (DSEI)
8/23/2007	73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL	341REGISTERED	Division of Southeast Imports (DSEI)
8/23/2007	78NWRKIT, CATHETER, FOLEY (EXCLUDES HIV TESTING)	341REGISTERED	Division of Southeast Imports (DSEI)
8/23/2007	78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)	341REGISTERED	Division of Southeast Imports (DSEI)
4/13/2007	85HFWCLAMP, UMBILICAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/13/2007	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/13/2007	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/13/2007	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/13/2007	80JOLCATHETER AND TIP, SUCTION	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/13/2007	80GAZTUBING, NONINVASIVE	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/13/2007	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/13/2007	79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/13/2007	79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/13/2007	85HDZKNIFE, CERVICAL CONE	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/13/2007	78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/13/2007	74DXQCUFF, BLOOD-PRESSURE	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/13/2007	80LKBPAD, ALCOHOL, DEVICE DISINFECTANT	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/13/2007	80FLKTHERMOMETER, CLINICAL MERCURY	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/16/2006	85HIBSPECULUM, VAGINAL, NONMETAL	508NO 510(K)	Florida District Office (FLA-DO)
10/16/2006	80FLKTHERMOMETER, CLINICAL MERCURY	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/14/2006	77KBLDEPRESSOR, METAL TONGUE, ENT	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
7/14/2006	79FXXMASK, SURGICAL	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
7/14/2006	85HDZKNIFE, CERVICAL CONE	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
7/14/2006	76EFNCOTTON, ROLL	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
7/14/2006	80LKBPAD, ALCOHOL, DEVICE DISINFECTANT	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
7/14/2006	80FMGSTOPCOCK, I.V. SET	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
7/14/2006	80FLLTHERMOMETER, ELECTRONIC, CLINICAL	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
7/14/2006	74DXQCUFF, BLOOD-PRESSURE	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
7/14/2006	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
7/14/2006	80GAZTUBING, NONINVASIVE	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
7/14/2006	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
7/14/2006	79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
7/14/2006	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
7/14/2006	78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
7/14/2006	80KZDINFUSOR, PRESSURE, FOR I.V. BAGS	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
7/14/2006	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
7/14/2006	87NBHACCESSORIES, ARTHROSCOPIC	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
7/11/2006	79MXETAPE AND BANDAGE, ADHESIVE (WITH DISINFECTANT)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	79GEMGAUZE, ABSORBABLE	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	80FMGSTOPCOCK, I.V. SET	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	79GECBRUSH, SCRUB, OPERATING-ROOM	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	85HEDDOUCHE APPARATUS, VAGINAL, THERAPEUTIC	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	85HFWCLAMP, UMBILICAL	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	79FXXMASK, SURGICAL	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	80FMEGOWN, EXAMINATION	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	80JOLCATHETER AND TIP, SUCTION	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	74LDESTETHOSCOPE, MANUAL	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	74DXQCUFF, BLOOD-PRESSURE	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	85HEDDOUCHE APPARATUS, VAGINAL, THERAPEUTIC	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	80FORAPPLICATOR, ABSORBENT TIPPED	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	88KIZDISH, TISSUE CULTURE	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	88KEWSLIDES, MICROSCOPE	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	80FPFBOTTLE, HOT/COLD WATER	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	80FMHCONTAINER, SPECIMEN	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	77KCPSYRINGE, ENT	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	80KZDINFUSOR, PRESSURE, FOR I.V. BAGS	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	85HGYPUMP, BREAST, NON-POWERED	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
1/27/2006	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
11/1/2005	80FQMBANDAGE, ELASTIC	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/1/2005	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/1/2005	74DXQCUFF, BLOOD-PRESSURE	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/1/2005	80LRTINDICATOR, STERILIZATION	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/1/2005	85HEDDOUCHE APPARATUS, VAGINAL, THERAPEUTIC	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/1/2005	80FMADEPRESSOR, TONGUE	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/1/2005	77KBLDEPRESSOR, METAL TONGUE, ENT	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/1/2005	85HFWCLAMP, UMBILICAL	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/1/2005	78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/1/2005	77KCPSYRINGE, ENT	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/1/2005	80FPFBOTTLE, HOT/COLD WATER	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/1/2005	78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/1/2005	80FMEGOWN, EXAMINATION	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/1/2005	79FXXMASK, SURGICAL	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/1/2005	80FLLTHERMOMETER, ELECTRONIC, CLINICAL	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Shanghai Neo-Medical Import & Export Co., Ltd.'s FDA import refusal history?

Shanghai Neo-Medical Import & Export Co., Ltd. (FEI: 3005327291) has 103 FDA import refusal record(s) in our database, spanning from 11/1/2005 to 10/23/2009.

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. Shanghai Neo-Medical Import & Export Co., Ltd.'s FEI number is 3005327291.

What types of violations has Shanghai Neo-Medical Import & Export Co., Ltd. received?

Shanghai Neo-Medical Import & Export Co., Ltd. has been cited for 3 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 Shanghai Neo-Medical Import & Export Co., Ltd. come from?

All FDA import refusal data for Shanghai Neo-Medical Import & Export 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.