Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012516784

FEI Number

3012516784

Entity Name

NG BIOTECH

City/State/Country

GUIPRY Bretagne, FR

Establishment Address

ZA Courbouton Secteur 1, GUIPRY Bretagne 35480, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NG BIOTECH (Owner Number: 10061777)

Owner / Operator Contact Address

ZA Courbouton Secteur 1, GUIPRY, FR-BRE 35480, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243499

PMA Number

N/A

All Registered Proprietary Names

NG-Test CTX-M Multi

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PTJ	Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates	Microbiology	Class 2	866.1640	2025-06-11

Official Correspondent

Jean Baptiste BAUDIER

US Agent Details

Ashleigh Rickey Business: Hardy Diagnostics Email: RickeyA@hardydiagnostics.com Phone: (805) 3462766

Related Public Records

Same Entity

NG BIOTECH

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3009963993	AZER SCIENTIFIC, INC.	Morgantown, PA, US
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN
3038274470	BRAINMATTERZ, INC	McKinney, TX, US
3012404174	LABORATORIO CHIMICO FARMACEUTICO A. SELLA SRL.	Schio Vicenza, IT
3042364673	NEURALYTIX LLC	Fruita, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012516784. Last updated year: 2026. Please use registration number 3012516784 when referencing this establishment in official correspondence.