Biosafe S A

FDA Filings

This page includes the latest FDA filings for Biosafe S A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3004728017
• FEI Number: 3004728017
• Name: Linda Lemieux
• Owner & Operator: BIOSAFE SA
• Contact Address: ROUTE DU PETIT-EYSINS 1 --; EYSINS, VAUD CH-NOTA 1262 CH
• US Agent:
  • Linda Lemieux
  • 508 6833790
  • linda.lemieux@ge.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 100 Results Way ; Marlborough, MA 01752 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 7640125650396 Biosafe S.A.	CryoSC-D Freezing Bag 10032	2018-07-06
GUDID 07640125650570 Biosafe S.A.	CryoSC-Db Seal positioner 7035	2018-07-06
GUDID 07640125650563 Biosafe S.A.	CryoSC-D Seal positioner 7026	2018-07-06
GUDID 07640125650556 Biosafe S.A.	Insertion Tool 7030	2018-07-06
GUDID 07640125650549 Biosafe S.A.	Metal Storage Canister 7012	2018-07-06
GUDID 07640125650518 Biosafe S.A.	Overwrap Bag 4085	2018-07-06
GUDID 07640125650501 Biosafe S.A.	Traceability Labels for Bioarchive 7031	2018-07-06
GUDID 07640125650495 Biosafe S.A.	Traceability Labels for cryopreservation 7011	2018-07-06
GUDID 07640125650419 Biosafe S.A.	CryoSC-Db Freezing Bag 10041	2018-07-06
GUDID 07640125650372 Biosafe S.A.	CryoSC-S Freezing Bag 10023	2018-07-06
GUDID 07640125650594 Biosafe S.A.	Sepax RM 14100	2018-03-29
GUDID 07640125650587 Biosafe S.A.	Sepax 2 14000	2018-03-29
GUDID 07640125650488 Biosafe S.A.	Press Modular 7040	2018-03-29
GUDID 07640125650471 Biosafe S.A.	DMSO Vial Adaptator 8 ml 6089	2018-03-29
GUDID 07640125650464 Biosafe S.A.	DMSO Vial Adaptator 7 ml 6076	2018-03-29
GUDID 07640125650457 Biosafe S.A.	Separation Chamber Holder 6033	2018-03-29
GUDID 07640125650440 Biosafe S.A.	Kit Connector 7033	2018-03-29
GUDID 07640125650433 Biosafe S.A.	Sample Calibrator 6074	2018-03-29
GUDID 07640125650426 Biosafe S.A.	Sample Calibrator 6075	2018-03-29
GUDID 07640125650358 Biosafe S.A.	Double Spike Accessory 10043	2018-03-29
GUDID 07640125650334 Biosafe S.A.	DMSO Extension Line 10022	2018-03-29
GUDID 07640125650310 Biosafe S.A.	Regenerative medicine-Single-use kits 10008	2018-03-29
GUDID 07640125650297 Biosafe S.A.	Regenerative medicine-Single-use kits 10006	2018-03-29
GUDID 07640125650273 Biosafe S.A.	Stem Cell Banking-Single-use kits 10039	2018-03-29
GUDID 07640125650266 Biosafe S.A.	Stem Cell Banking-Single-use kits 10030	2018-03-29
GUDID 07640125650228 Biosafe S.A.	Stem Cell Banking-Single-use kits 10037	2018-03-29
GUDID 07640125650204 Biosafe S.A.	Stem Cell Banking-Single-use kits 10025	2018-03-29
GUDID 07640125650181 Biosafe S.A.	Stem Cell Banking-Single-use kits 10036	2018-03-29
GUDID 07640125650167 Biosafe S.A.	Stem Cell Banking-Single-use kits 10024	2018-03-29
GUDID 07640125650143 Biosafe S.A.	Sepax single-use kit 10015	2018-03-29
GUDID 07640125650112 Biosafe S.A.	Sepax single-use kit 10001	2018-03-29
GUDID 07640125650105 Biosafe S.A.	Sepax single-use kit 10005	2018-03-29
GUDID 07640125650082 Biosafe S.A.	Regenerative medicine-Single-use kits 10034	2018-03-29
GUDID 07640125650051 Biosafe S.A.	Stem Cell Banking-Single-use kits 10017	2018-03-29
GUDID 07640125650044 Biosafe S.A.	Sterile Sampling Line 10028	2018-03-29
GUDID 07640125650020 Biosafe S.A.	Sterile Sampling Line 10010	2018-03-29
PMN BK140203 Biosafe SA	510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices	2015-02-13
PMN BK110022 | OAO Linda Lemieux [BIOSAFE SA]	Single-use kit CS-570.x	2011-12-07
PMN BK110022 | OAO Linda Lemieux [BIOSAFE SA]	Single-use kit CS-540.x	2011-12-07
PMN BK110022 | OAO Linda Lemieux [BIOSAFE SA]	Single-use kit CS-530.x	2011-12-07
PMN BK110022 | OAO Linda Lemieux [BIOSAFE SA]	Single-use kit CS-430.x	2011-12-07
PMN BK110022 | OAO Linda Lemieux [BIOSAFE SA]	Sepax 2 S-100	2011-12-07
PMN BK110022 | OAO Linda Lemieux [BIOSAFE SA]	Accessories: FA-100.1, AK-100, AK-101	2011-12-07
PMN BK110022 Biosafe SA	510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices	2011-10-28
PMN BK090037 | OAO Linda Lemieux [BIOSAFE SA]	FB-100.2b	2010-10-29
PMN BK090037 | OAO Linda Lemieux [BIOSAFE SA]	FB-100.2	2010-10-29
PMN BK090037 | OAO Linda Lemieux [BIOSAFE SA]	FB-100.1	2010-10-29
PMN BK090037 | OAO Linda Lemieux [BIOSAFE SA]	CryoSC-S	2010-10-29
PMN BK090037 | OAO Linda Lemieux [BIOSAFE SA]	CryoSC-Db	2010-10-29
PMN BK090037 | OAO Linda Lemieux [BIOSAFE SA]	CryoSC-D	2010-10-29
PMN BK090037 Biosafe SA	510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices	2010-03-22
JQC Linda Lemieux [BIOSAFE SA]	Single use kits CS-900.x	2009-07-15
JQC Linda Lemieux [BIOSAFE SA]	Single use kits CS-600.x	2009-07-15
JQC Linda Lemieux [BIOSAFE SA]	Single use kits CS-490.x	2009-07-15
JQC Linda Lemieux [BIOSAFE SA]	Single use kits CS-470.x	2009-07-15
JQC Linda Lemieux [BIOSAFE SA]	SEPAX 2 RM	2009-07-15
JQC Linda Lemieux [BIOSAFE SA]	Accessory FA-200.1	2009-07-15