FDA.reportPublic FDA data

BIOSPHERE MEDICAL, S.A.

Matched from indexed company URL: Biosphere Medical, S.A.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96157283002808761BIOSPHERE MEDICAL, S.A.1N2026-01-01Parc des Nations - Paris Nord 2, 383 rue de la Belle Etoile 95700 ROISSY-EN-FRANCE, FRANCE Roissy Val-d'Oise FR 95700

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2042341971021489K192480Torpedo Gelatin FoamKRD2019-11-21
2042341785192182K183578Torpedo Gelatin FoamKRD2019-06-18
2042341924766376K183120EmboCube Embolization GelatinKRD2019-08-06
2042341040941059K181300Embosphere MicrospheresKRD2018-07-16
2042341925430052K181021EmboCube Embolization GelatinKRD2018-09-27
2042341379478253K172372QuadraSphere MicrospheresKRD2017-09-06
2042341281048316K153102QuadraSphere MicrospheresKRD2015-11-23
2042341282527085K062126EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135DQO2006-08-09
2042341175674557K061171SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XXDQX2006-06-02
2042341313123665K021397EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATIONNAJ2002-11-22
2042341603963771K010026EMBOGOLD MICROSPHEREHCG2001-06-21
2042341431642111DEN160040Embosphere MicrospheresNOY2017-06-21
2042341160610720
2042341531031874

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KRD82019-11-21
NOY12017-06-21
DQO12006-08-09
DQX12006-06-02
NAJ12002-11-22
HCG12001-06-21

PMN#