Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019800450

FEI Number

3019800450

Entity Name

NGNY DEVICES S.L.

City/State/Country

Esplugues de Llobregat Barcelona, ES

Establishment Address

Avinguda de Cornella, 144, 6, Esplugues de Llobregat Barcelona 08950, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NGNY DEVICES S.L. (Owner Number: 10082052)

Owner / Operator Contact Address

Avinguda de Cornella, 144, 6, Esplugues de Llobregat, ES-B 08950, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NGNY DEVICES SL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2021-06-10

Official Correspondent

Maite Viladomat

US Agent Details

Yevgenia Jenny Sarkisian Business: Siemens Healthcare Diagnostics Inc. Email: yevgenia.sarkisian@siemens-healthineers.com Phone: (302) 4375949

Related Public Records

Same Entity

NGNY DEVICES S.L.

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-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019800450. Last updated year: 2026. Please use registration number 3019800450 when referencing this establishment in official correspondence.