GOTOP MEDICAL INC

FDA Device Registration & Listing · Saint Paul, MN, US · Registration 3011027014

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011027014
FEI Number
3011027014
Entity Name
GOTOP MEDICAL INC
City/State/Country
Saint Paul, MN, US
Establishment Address
1000 Westgate Dr Ste 125, Saint Paul, MN 55114, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
GOTOP Medical Inc (Owner Number: 10047270)
Owner / Operator Contact Address
1000 Westgate Drive, Suite 125, Saint Paul, MN 55114, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K941781
PMA Number
N/A

All Registered Proprietary Names

RigiScan Plus Rigidity Assessment System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LIL Monitor, Penile Tumescence Unknown Class U N/A 2014-07-30

Official Correspondent

Gordon Gui

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GOTOP Medical Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011027014. Last updated year: 2026. Please use registration number 3011027014 when referencing this establishment in official correspondence.
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