Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009307663

FEI Number

3009307663

Entity Name

Trelleborg Sealing Solutions Weobley Limited

City/State/Country

Weobley Herefordshire, GB

Establishment Address

Kington Road Industrial Estate, Weobley Herefordshire HR48QU, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Trelleborg Sealing Solutions Plymouth LLC (Owner Number: 9102441)

Owner / Operator Contact Address

1100 XENIUM LANE NORTH, --, Minneapolis, MN 55441, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OvuSense Fertility Monitor System. M026 OvuCore Vaginal Sensor, M426 OvuFirst Skin Worn Sensor and M032 OvuSense App. OvuSense Saint

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHD	Device, Fertility Diagnostic, Proceptive	Unknown	Class U	N/A	2024-05-09
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2022-11-28

Official Correspondent

No official correspondent registered.

US Agent Details

Heaven Clausen Business: Trelleborg Sealing Solutions Plymouth LLC Email: heaven.clausen@trelleborg.com Phone: (763) 9529171

Related Public Records

Same Entity

Trelleborg Sealing Solutions Plymouth LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004126422	Trelleborg Sealing Solutions Litchfield	Litchfield, MN, US
3002939152	Trelleborg Sealing Solutions River Falls	River Falls, WI, US
3008770653	Trelleborg Sealing Solutions Suzhou Company Limited	Suzhou Jiangsu, CN

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009307663. Last updated year: 2026. Please use registration number 3009307663 when referencing this establishment in official correspondence.