Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011787398

FEI Number

3011787398

Entity Name

BENELI AB

City/State/Country

Helsingborg Skane, SE

Establishment Address

Porfyrgatan 5, Helsingborg Skane 25468, SE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Beneli AB (Owner Number: 10049488)

Owner / Operator Contact Address

Porfyrgatan 5, Helsingborg, SE-M 25468, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Snap Strip Universal Patch Patch Patch electrode Fast Fix ECG Electrode MCOT patch BodyGuardian Mini Strip

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2015-06-08

Official Correspondent

Pernilla Nero Vikso

US Agent Details

Maureen OConnell Business: OConnell Regulatory Consultants, Inc. Email: maureen@oconnellregulatory.com Phone: (978) 2071245

Related Public Records

Same Entity

Beneli AB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07

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3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3017425211	LOHMANN PRECISION DIE CUTTING, LLC	Orange, VA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011787398. Last updated year: 2026. Please use registration number 3011787398 when referencing this establishment in official correspondence.