FDA.reportPublic FDA data

WELL LEAD MEDICAL CO. LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30104008653010400865WELL LEAD MEDICAL CO. LTD1N2026-01-01No. 47 Guomao Avenue South Panyu GUANGZHOU Guangdong CN 511434

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1590721901537040K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactGBM2025-03-05
1590721361385255K220722PVC Hydrophilic Urethral CatheterEZD2023-05-22
1590721534661524K211814Wellead Endoscopic SealODC2022-01-14
1590721158170344K211543Wei Nasal Jet TubeBTR2022-07-21
1590721959814434K203119ClearPetra Suction-Evacuation SheathFED2020-12-09
1590721898627059K202134Well Lead All Silicone Foley Catheter with Temperature SensorEZL2021-04-08
1590722002287356K182739Endotracheal Tube with Evacuation LumenBTR2019-12-11
1590721746841010K162340Stomach TubeKNT2017-10-11
1590721183628865K161110ClearPetra Suction-Evacuation SheathFED2016-10-12
1590721239563818K160801Well Lead Extraction BagGCJ2016-11-29
1590721402027945K151084Well Lead Ureteral Access SheathFED2016-01-07
1590721672696508K142563Well Lead PVC Urethral CatheterEZD2014-10-28
1590721109445814K140667WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETEREZL2014-12-15
1590721498753417K133615WELL LEAD PVC HYDROPHILIC URETHRAL CATHETEREZD2014-02-24
1590721733950047K110269WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORALBTR2011-08-26
1590722069064932K101721WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULABTO2011-03-24
1590721044176442K092886WELL LEAD ENDOBRONCHIAL TUBESCBI2010-03-11
1590722032460237K091516WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOREZL2009-10-16
1590721612801013K082815WELL LEAD SILICONE AND LATEX FOLEY CATHETERSEZL2008-10-08
1590721174202580K073383WELL LEAD REINFORCED ENDOTRACHEAL TUBEBTR2008-07-10
1590722042495547K042684WELL LEAD TRACHEOSTOMY TUBEBTO2005-02-17
1590721540106012K042683WELL LEAD ENDOTRACHEAL TUBEBTR2005-02-18
1590721021006046
1590721432231268
1590721432771327
1590721548086839
1590721880614571
1590721954371258
1590721002245367
1590721027427150
1590721072244466
1590721092434957
1590721119383584
1590721141332152
1590721160870750
1590721249519256
1590721301101302
1590721393738478
1590721397941578
1590721409458861
1590721412548713
1590721419287398
1590721493987435
1590721504387881
1590721521957321
1590721539090543
1590721561479747
1590721571395494
1590721581579465
1590721586175567
1590721614682369
1590721621509563
1590721653893078
1590721683397047
1590721684158386
1590721689292967
1590721692922524
1590721733824912
1590721778601303
1590721785197989
1590721789642730
1590721836741053
1590721873143213
1590721989600513
1590721991029623
1590721993592777
1590722006866386
1590722007079085
1590722027608771
1590722070346788

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BTR52022-07-21
EZL42021-04-08
EZD32023-05-22
FED32020-12-09
KNT22017-10-11
BTO22011-03-24
GBM12025-03-05
ODC12022-01-14
GCJ12016-11-29
CBI12010-03-11

PMN#