FDA.reportPublic FDA data

SYNAPTIC MEDICAL LIMITED

Matched from indexed company URL: Synaptic Medical Corporation

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30102001633010200163SYNAPTIC MEDICAL LIMITED1N2026-01-01No.9 Tongji North Road Beijing Economic-Technological Development Area Beijing CN 100176
30134007083013400708SYNAPTIC MEDICAL CORPORATION1Y2026-01-011959 Kellogg Ave Carlsbad CA US 92008

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
06948806322107NA - Steerable Intracardiac Catheter Introducer Kit+861051297209regulatory@synapticmed.com
06948806354016NA - Transseptal Needle+861051297209service@synapticmed.com.cn
06948806354023NA - Transseptal Needle+861051297209service@synapticmed.com.cn

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2055481656326708K240246Accusafe Transseptal Guidewire (GTR31180, GTR31230)DRC2024-07-26
2055481094488765K233900Nordica PV Cryo Mapping CatheterDRF2024-09-06
2055481186528084K233708NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)DYB2024-02-16
2055481331563185K203793RithmID-SD Steerable Diagnostic Electrophysiology CatheterDRF2022-02-14
2055481240664438K151936Steerable Intracardiac Catheter Introducer Kit and Transseptal NeedleDYB2015-12-04
1985191294939805K151936Steerable Intracardiac Catheter Introducer Kit and Transseptal NeedleDYB2015-12-04
1985191060878034K133028RITHM ID ELECTROPHYSIOLOGY CATHETERDRF2014-03-04
2055481723822742K133028RITHM ID ELECTROPHYSIOLOGY CATHETERDRF2014-03-04
2055481006920732K132943INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLEDRC2014-08-29
1985191879625728K132943INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLEDRC2014-08-29
1985191014759920

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DRF42024-09-06
DRC32024-07-26
DYB32024-02-16

PMN#

GUDID#