Beurer Gmbh & Co.

⚠️ Moderate Risk

FEI: 3003571778 • Ulm, Baden-Wurttemberg • GERMANY

FEI

FEI Number

3003571778

📍

Location

Ulm, Baden-Wurttemberg

🇩🇪

Country

GERMANY

🏢

Address

Soflinger Str. 218, , Ulm, Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

49.2

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/29/2024

Latest Refusal

9/5/2003

Earliest Refusal

Score Breakdown

Violation Severity

56.6×40%

Refusal Volume

44.6×30%

Recency

62.1×20%

Frequency

7.3×10%

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

11811×

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).

50810×

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.

32806×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

3413×

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).

24801×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

841×

RX DEVICE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.

Refusal History

Date	Product	Violations	Division
2/29/2024	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
3/15/2019	74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
1/9/2018	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2017	74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE	3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
9/8/2015	74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
1/16/2015	74MHXMONITOR, PHYSIOLOGICAL, PATIENT	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/15/2013	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/8/2007	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG	New Orleans District Office (NOL-DO)
3/8/2007	79GEXPOWERED LASER SURGICAL INSTRUMENTS	118NOT LISTED 126FAILS STD 237NO PMA	New Orleans District Office (NOL-DO)
11/28/2006	89NHNLAMP, NON-HEATING, FOR ADJUNCTIVE USE IN PAIN THERAPY	2480RXPERSONAL 508NO 510(K) 84RX DEVICE	Detroit District Office (DET-DO)
10/18/2006	95L22LASER PRODUCT FOR NON-MEDICAL USE	118NOT LISTED 508NO 510(K)	New York District Office (NYK-DO)
8/31/2006	95L22LASER PRODUCT FOR NON-MEDICAL USE	118NOT LISTED 508NO 510(K)	New York District Office (NYK-DO)
2/28/2005	79GEXPOWERED LASER SURGICAL INSTRUMENTS	118NOT LISTED	New York District Office (NYK-DO)
9/5/2003	89ILYLAMP, INFRARED, THERAPEUTIC HEATING	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
9/5/2003	80LSXCONTROLLER, CLOSED-LOOP, BLOOD-PRESSURE	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Beurer Gmbh & Co.'s FDA import refusal history?

Beurer Gmbh & Co. (FEI: 3003571778) has 15 FDA import refusal record(s) in our database, spanning from 9/5/2003 to 2/29/2024.

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. Beurer Gmbh & Co.'s FEI number is 3003571778.

What types of violations has Beurer Gmbh & Co. received?

Beurer Gmbh & Co. has been cited for 9 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 Beurer Gmbh & Co. come from?

All FDA import refusal data for Beurer Gmbh & Co. 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.