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BIOSPHERE MEDICAL, S.A.

France · Roissy

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 0Class II 4Class III 0

plus 7 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

2 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

4active device licences

Class II 4

13 including historic records

TWTaiwanTFDA

2valid device licences

Class III 2

SGSingaporeHSA SMDR

2device registrations

CLASS D 2

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

4active ARTG entries

Class III 3IIb 1

HKHong KongMDACS

6valid listings

Class II 1Class IV 5

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

1active registrations

Class 3 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States7 registration records, 18 510(k), 0 PMA

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: BIOSPHERE MEDICAL, S.A. · BIOSPHERE MEDICAL INC. · BIOSPHERE MEDICAL S.A.

FDA 510(k) clearances by year

12000

22001

12002

32006

12012

22015

22017

22018

32019

12025

FDA listed device types

Device, Neurovascular Embolization 1Agents, Embolic, For Treatment Of Uterine Fibroids 1Device, Vascular, For Promoting Embolization 1Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250971	Embosphere Microspheres	2025-05-16
US	K192480	Torpedo Gelatin Foam	2019-11-21
US	K183120	EmboCube Embolization Gelatin	2019-08-06
CA	65169	EMBOCATH	Class II
CA	65170	SEGWAY HYDROPHILIC GUIDEWIRE	Class II
CA	72130	SEQUITOR STEERABLE GUIDEWIRE	Class II