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Bioplate, Inc.

US

Last updated September 17, 2026

Information

Country
US
Address
570 S. Melrose St., Placentia, CA, 92870
Website
bioplate.com
LinkedIn
—
Facebook
—
Phone
888-246-7528
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
1000518793
DUNS Number
838734093

Catalogue (1156)

Page 13 of 24
DeviceModel / ReferenceRegistriesClassStatus
CranioFit KT-T9L2H1
FDA UDI
Class IIActive
CranioFit KT-T3L10H2
FDA UDI
Class IIActive
Bioplate® 81-5768
FDA UDI
Class IIActive
CranioFit KT-T7L2H1
FDA UDI
Class IIActive
Bioplate® 81-5746
FDA UDI
Class IIActive
Bioplate® 81-5744[US]
FDA UDI
Class IIActive
Bioplate® 81-2003-CP
FDA UDI
Class IIActive
Bioplate® 81-3136-CP
FDA UDI
Class IIActive
Bioplate® 81-3586
FDA UDI
Class IIActive
CranioFit KT-T6L15H2
FDA UDI
Class IIActive
Bioplate® 81-3482
FDA UDI
Class IActive
Bioplate® 81-3024
FDA UDI
Class IIActive
Bioplate® 81-3578
FDA UDI
Class IIActive
Bioplate® 81-3180-CP
FDA UDI
Class IIActive
Bioplate® P4ST-04-24
FDA UDI
Class IIActive
CranioFit KT-T4L15H2
FDA UDI
Class IIActive
Bioplate® 81-5769
FDA UDI
Class IIActive
Bioplate® 81-3136[US]
FDA UDI
Class IIActive
Bioplate® P4XB-08-39
FDA UDI
Class IIActive
Bioplate® 81-5746[US]
FDA UDI
Class IIActive
Bioplate® SCE2-10-05
FDA UDI
Class IIActive
Bioplate® P8BX-04-09[US]
FDA UDI
Class IIActive
Bioplate® 81-5727
FDA UDI
Class IIActive
Bioplate® P2ZR-04-16
FDA UDI
Class IIActive
Bioplate® 81-3026
FDA UDI
Class IIActive
Bioplate® 81-3111
FDA UDI
Class IActive
Bioplate® 81-3142[US]
FDA UDI
Class IIActive
Bioplate® ASHB-42
FDA UDI
Class IActive
CranioFit KT-T9L4H1
FDA UDI
Class IIActive
Bioplate® 81-5892
FDA UDI
Class IIActive
Bioplate® 81-5784
FDA UDI
Class IIActive
Bioplate® 81-2075[US]
FDA UDI
Class IIActive
Bioplate® 81-3564
FDA UDI
Class IActive
Bioplate® 81-3054-CP
FDA UDI
Class IIActive
Bioplate® 81-5894
FDA UDI
Class IIActive
CranioFit KT-T4L4H1
FDA UDI
Class IIActive
Bioplate® 81-5726
FDA UDI
Class IIActive
Bioplate® SCR2-06-01
FDA UDI
Class IIActive
CranioFit KT-T5L4H1
FDA UDI
Class IIActive
Bioplate® 81-2066[US]
FDA UDI
Class IIActive
CranioFit KT-T5L10H2
FDA UDI
Class IIActive
Bioplate® SCE8-05-01
FDA UDI
Class IIActive
Bioplate® 81-5743
FDA UDI
Class IIActive
Bioplate® SCR4-12-01
FDA UDI
Class IIActive
Bioplate® 81-4208-CP
FDA UDI
Class IActive
Bioplate® 81-2068[US]
FDA UDI
Class IIActive
Bioplate® 81-3358
FDA UDI
Class IIActive
Bioplate® SCE4-07-05[US]
FDA UDI
Class IIActive
Bioplate® 81-2009[US]
FDA UDI
Class IIActive
Bioplate® 81-3354
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (2)

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 31, 2010Z-0143-2012—terminated

There is potential defect in seal of the sterile barrier containing the device.

Sep 12, 2006Z-0043-2007—terminated

Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized.