Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004729605

FEI Number

3004729605

Entity Name

NEOVENTA MEDICAL AB

City/State/Country

Molndal Vastra Gotaland, SE

Establishment Address

Norra Agatan 32, Molndal Vastra Gotaland 43135, SE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Neoventa Medical AB (Owner Number: 10095143)

Owner / Operator Contact Address

Norra Agatan 32, Molndal, SE-O 43135, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243291

PMA Number

N/A

All Registered Proprietary Names

Goldtrace Fetal Spiral Electrode (FSE)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGP	Electrode, Circular (Spiral), Scalp And Applicator	Obstetrics/Gynecology	Class 2	884.2675	2026-01-28

Official Correspondent

Erik Olsson

US Agent Details

Cherita James Business: Pro Pharma Group Email: cherita.james@propharmagroup.com Phone: (347) 9540624

Related Public Records

Same Entity

Neoventa Medical AB

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004729605. Last updated year: 2026. Please use registration number 3004729605 when referencing this establishment in official correspondence.