Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014027738

FEI Number

3014027738

Entity Name

BIOSERENITY MEDICAL DEVICES GROUP

City/State/Country

PARIS CEDEX 13 Ile-de-France, FR

Establishment Address

6/8 rue Jean Antoine de Baif, PARIS CEDEX 13 Ile-de-France 75013, FR

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

BIOSERENITY MEDICAL DEVICES GROUP (Owner Number: 10089585)

Owner / Operator Contact Address

6/8 rue Jean Antoine de Baif, Paris, FR-IDF 75013, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243788

PMA Number

N/A

All Registered Proprietary Names

IceCap Neonate IceCap 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2025-04-16

Official Correspondent

Pierre Emerich

US Agent Details

Kathy Fischer Business: VCLS Inc. Email: kfischer@voisinconsulting.com Phone: (908) 7041691

Related Public Records

Same Entity

BIOSERENITY MEDICAL DEVICES GROUP

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
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Similar Registrations

Registration Number	Establishment Name	Location
3015614098	CGX, LLC	San Diego, CA, US
3015429360	SHAOXING YINGTUO HEALTHCARE CO.,LTD.	Shaoxing Zhejiang, CN
3004695199	INCEREB LTD	Dublin Dun Laoghaire-Rathdown, IE
3005581220	SPES MEDICA S.P.A	BATTIPAGLIA Salerno, IT
9616086	DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014027738. Last updated year: 2026. Please use registration number 3014027738 when referencing this establishment in official correspondence.