Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615728

FEI Number

3002808761

Entity Name

BIOSPHERE MEDICAL, S.A.

City/State/Country

Roissy Val-d'Oise, FR

Establishment Address

Parc des Nations - Paris Nord 2, 383 rue de la Belle Etoile, 95700 ROISSY-EN-FRANCE, FRANCE, Roissy Val-d'Oise 95700, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Merit Medical Systems, Inc. (Owner Number: 1721504)

Owner / Operator Contact Address

1600 West Merit Parkway, --, South Jordan, UT 84095, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192480

PMA Number

N/A

All Registered Proprietary Names

EmboGold Microspheres EmboCube Gelatin Embolization Embosphere Microspheres QuadraSphere Q2 Microspheres QuadraSphere Microspheres Bearing nsPVA Embolization Particles Bearing nsPVA Express Torpedo Gelatin Foam

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2017-01-26
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2019-08-16
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-07-31
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2018-07-31
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2018-07-31
NOY	Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia	Gastroenterology, Urology	Class 2	876.5550	2018-07-31
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-09-08
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2017-09-08
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2013-06-20
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2013-06-20
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2024-02-06
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2024-02-06
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2022-01-18

Official Correspondent

No official correspondent registered.

US Agent Details

JOHN KNORPP Business: MERIT MEDICAL SYSTEMS, INC Email: jknorpp@merit.com Phone: (801) 2084389

Related Public Records

Same Entity

Merit Medical Systems, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3021179744	VIEW POINT MEDICAL, INC.	Carlsbad, CA, US
3012276280	KA Medical	Arden Hills, MN, US
2032338	Merit Medical Systems, Inc.	ALISO VIEJO, CA, US
1125782	MERIT MEDICAL SYSTEMS, INC	Chester, VA, US
3010665433	Merit Medical Systems, Inc.	Houston, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K951256	Target Therapeutics	DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)	1995-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2017	Merit Medical Systems, Inc.	2	Merit Inflation Syringe Kit. Catalog Number KOS-02857
Z-0026-2020	Merit Medical Systems, Inc.	2	Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Z-0027-2020	Merit Medical Systems, Inc.	2	Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580

Similar Registrations

Registration Number	Establishment Name	Location
2029275	Sterigenics U.S., LLC	Corona, CA, US
3008853977	Stryker Neurovascular	Fremont, CA, US
2022435	Sterigenics U.S., LLC	Tustin, CA, US
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US
3015550451	MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615728. Last updated year: 2026. Please use registration number 9615728 when referencing this establishment in official correspondence.