Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043520111

FEI Number

3043520111

Entity Name

BOILLAT DECOLLETAGE SA

City/State/Country

Loveresse Bern, CH

Establishment Address

Benevis 2, Loveresse Bern 2732, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Boillat Decolletage SA (Owner Number: 10095247)

Owner / Operator Contact Address

Benevis 2, Loveresse, CH-BE 2732, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CMORE® CT System CMORE® CT System Navigated Instruments

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-02-11
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2026-02-11

Official Correspondent

Nicolas Boillat

US Agent Details

Franz Menean Business: MEDAGENT, Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

Boillat Decolletage SA

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
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
K161478	Xenco Medical, LLC	Xenco Medical Posterior Cervical System	2016-09-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

Similar Registrations

Registration Number	Establishment Name	Location
3002743211	NORTHERN DIGITAL, INC.	WATERLOO Ontario, CA
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US
3020983478	ORTHOKEY ITALIA SRL	Firenze, IT
3014725904	Medtronic Medical Costa Rica S.R.L.	Coyol Alajuela, CR
3018405359	A7 INTEGRATION	Granby Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043520111. Last updated year: 2026. Please use registration number 3043520111 when referencing this establishment in official correspondence.