Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005246636

FEI Number

3005246636

Entity Name

SILCOTECH NORTH AMERICA INC

City/State/Country

Bolton Ontario, CA

Establishment Address

54 Nixon Road, Bolton Ontario L-7E1W2, CA

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Silcotech North America Inc (Owner Number: 10088541)

Owner / Operator Contact Address

54 Nixon Road, Bolton, CA-ON L-7E1W2, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2023-08-10

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Silcotech North America Inc

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 3005246636. Last updated year: 2026. Please use registration number 3005246636 when referencing this establishment in official correspondence.