Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616532

FEI Number

3003116993

Entity Name

ETS Rene Mandrillon

City/State/Country

Saint Pierre Saint-Pierre-et-Miquelon, FR

Establishment Address

3 Zone Industrielle La Combe, Saint Pierre Saint-Pierre-et-Miquelon 39150, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SARL Rene Mandrillon (Owner Number: 9042187)

Owner / Operator Contact Address

3 Zone Industrielle La Combe, Saint Pierre, FR-NOTA F-39150, FR

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
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2000-07-17

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

SARL Rene Mandrillon

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616532. Last updated year: 2026. Please use registration number 9616532 when referencing this establishment in official correspondence.