FDA.reportPublic FDA data

SOFREGEN MEDICAL INC.

Matched from indexed company URL: Sofregen Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30134171883013417188SOFREGEN MEDICAL INC.1N2020-04-25200 BOSTON AVE STE 1100 Medford MA US 02155

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B6119467707SERI - SERI Surgical Scaffold 15cm x 25cm617 651 8871prodsurv@sofregen.com
B6119467808SERI - SERI Surgical Scaffold 20cm x 30cm617 651 8871prodsurv@sofregen.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2011561048317567K180631Silk VoiceMIX2018-11-08
2011561438556700K172545SERI ContourOXF2017-09-22
2011561579579272K123128SERI SURGICAL SCAFFOLDOXF2013-04-25

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OXF22017-09-22
MIX12018-11-08

PMN#

GUDID#