Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019916034

FEI Number

3019916034

Entity Name

QUANTIEMEPLUS SA

City/State/Country

Gland Vaud, CH

Establishment Address

Route des Avouillons 14, Gland Vaud 1196, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

QuantiemePlus SA (Owner Number: 10082451)

Owner / Operator Contact Address

Route des Avouillons 14, Gland, CH-VD 1196, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ReamerPlus D-Reamer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTO	Reamer	Orthopedic	Class 1	888.4540	2021-07-29

Official Correspondent

Frederic Mani

US Agent Details

Doug Dockhorn Business: Veranex Inc. Email: usagent@veranex.com Phone: (919) 8276653

Related Public Records

Same Entity

QuantiemePlus SA

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019916034. Last updated year: 2026. Please use registration number 3019916034 when referencing this establishment in official correspondence.