FDA.reportPublic FDA data

WELLYSIS CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30299155373029915537WELLYSIS CORP.1N2027-01-018F, 425 Teheran-ro, Gangnam-gu, Seoul KR 06159

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
08800159500015S-Patch Ex - 0+8218002830info@wellysis.com
08800159500022S-Patch ExL - 0+8218002830info@wellysis.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3215461363594414K254255S-Patch CardioAIDPS2026-09-25
3215461915898023K233906S-Patch (S-Patch ExL)DSH2024-02-16
3215461690403075K231289S-Patch Ex Wearable ECG PatchDSH2023-08-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DSH22024-02-16
DPS12026-09-25

PMN#

GUDID#