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BIOREP TECHNOLOGIES, INC.

US

Last updated September 17, 2026

Information

Country
US
Address
15804 NW 57th Ave, Miami Lakes, FL, 33014
Website
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LinkedIn
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Facebook
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Email
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Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
3005593675
DUNS Number
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Catalogue (23)

DeviceModel / ReferenceRegistriesClassStatus
DeTACH Aortic Cross Clamp Delivery Device 1.0
FDA UDI
Class IIActive
MI Intercostal Retractor System (IRS) 222 Large Blade Set 3.0
FDA UDI
Class IActive
SUTURE BELT - Circumferential Suture Organizer 9.0
FDA UDI
Class IActive
MI Intercostal Retractor System (IRS) 222 Small Blade Set 3.0
FDA UDI
Class IActive
DeTACH - Detachable Aortic Cross Clamp Head - Large 1.0
FDA UDI
Class IIActive
JOSEPH LAMELAS Atrial Lift System 10.0
FDA UDI
Class IActive
DeTACH - Detachable Aortic Cross Clamp Head - Medium 1.0
FDA UDI
Class IIActive
Joseph Lamelas Intercostal Retractor System Rack 5.0
FDA UDI
Class IActive
MI Intercostal Retractor System (IRS) 222 Medium Blade Set 3.0
FDA UDI
Class IActive
MI DeTACH - Aortic Cross Clamp - Delivery System Sterilization Tray 1.0
FDA UDI
Class IActive
DeTACH - Detachable Aortic Cross Clamp Head - Small 1.0
FDA UDI
Class IIActive
Irrigation Syringe Attachment 1.0
FDA UDI
Class IActive
MI DeTACH - Aortic Cross Clamp - Delivery System Kit 1.0
FDA UDI
N/AActive
Joseph Lamelas Intercostal Retractor System 3.0
FDA UDI
Class IActive
DeTACH Aortic Cross Clamp Quick Release Device 1.0
FDA UDI
Class IIActive
MI Intercostal Retractor System Medium Double Swivel Blade Set 4.0
FDA UDI
Class IActive
COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle 7.0
FDA UDI
Class IActive
MI Intercostal Retractor System Small Double Swivel Blade Set 3.0
FDA UDI
Class IActive
Joseph Lamelas Intercostal Retractor System (IRS) 222 Sterilization Tray 1.0
FDA UDI
Class IActive
MI Intercostal Retractor System (IRS) 222 Extra Large Blade Set 3.0
FDA UDI
Class IActive
JOSEPH LAMELAS Knot Pusher 8.0
FDA UDI
Class IActive
MI CUFF - Aortic Root Exposure Device 4.0
FDA UDI
Class IActive
MI DeTACH K210006
FDA 510(k)
Class IIActive

Related Companies

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Mar 19, 2014Z-1538-2014—terminated

The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.