Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013382619

FEI Number

3013382619

Entity Name

SILCOPLAST AG

City/State/Country

Wolfhalden Appenzell Ausserrhoden, CH

Establishment Address

LUCHTEN 75, Wolfhalden Appenzell Ausserrhoden 9427, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Silcoplast AG, Luchten 75, CH-9427 Wolfhalden (Owner Number: 10089547)

Owner / Operator Contact Address

Luchten 75, Wolfhalden, CH-AR CH 9427, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Frida Fertility Conception Aid Cup

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HDR	Cap, Cervical	Obstetrics/Gynecology	Class 2	884.5250	2023-12-15

Official Correspondent

Philipp Gaus

US Agent Details

Jeff Davidson Email: jeff@fridababy.com Phone: (786) 5988227

Related Public Records

Same Entity

Silcoplast AG, Luchten 75, CH-9427 Wolfhalden

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 3013382619. Last updated year: 2026. Please use registration number 3013382619 when referencing this establishment in official correspondence.