Orbusneich Medical Inc

FDA Filings

This page includes the latest FDA filings for Orbusneich Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Orbusneich Medical Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1064498
FEI Number3002394096
NameORBUSNEICH MEDICAL, INC.
Owner & OperatorOrbusNeich Medical Company Limited (a company incorporated i
Contact AddressUnit 303 & 305, 3F, Building 20E Hong Kong Science Park
Sha Tin, N.T. HK-NA -- HK
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5363 NW 35th Ave
Fort Lauderdale, FL 33309 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198

FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
ORBUSNEICH MEDICAL, INC. [OrbusNeich Medical Company Limited (a company incorporated i]
Sapphire II Pro Coronary Dilatation Catheter2017-08-08
ORBUSNEICH MEDICAL, INC. [OrbusNeich Medical Company Limited (a company incorporated i]
Sapphire NC Plus Coronary Dilatation Catheter2017-08-08
OrbusNeich Medical Inc.
Sapphire II PRO2017-01-05
OrbusNeich Medical, Inc
Sapphire NC Plus2016-10-06
ORBUSNEICH MEDICAL, INC. [OrbusNeich Medical Company Limited (a company incorporated i]
Sapphire NC PTCA2011-09-08
ORBUSNEICH MEDICAL, INC. [OrbusNeich Medical Company Limited (a company incorporated i]
Sapphire PTCA2011-09-08
ORBUSNEICH MEDICAL, INC.
SAPPHIRE NC2011-09-01
ORBUSNEICH MEDICAL, INC.
SAPPHIRE2011-08-09

Similar & Related FDA Registered Companies

Related Finance Registrations
NCAGE Code62K35ORBUSNEICH MEDICAL INC.
CAGE Code62K35ORBUSNEICH MEDICAL INC.
DUNS005003095ORBUSNEICH MEDICAL INC.
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