FDA.reportPublic FDA data

HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30113530163011353016HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD.1N2026-01-01Accurate Industrial Park, No.108, Zhixian Road, Xuelian Communit Changsha Hunan CN 410208

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1781031016623800K252748Pelvic Floor Exerciser (PF01)HIR2026-04-27
1781031384372468K243049Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)DQA2025-01-02
1781031663254886K240808Pulse Oximeter (WS20A)DQA2024-10-03
1781031577989899K171241Pulse OximeterDQA2018-03-27
1781031635153770K141105PULSE OXIMETERDQA2014-12-04
1781031220952281
1781031308946719
1781031811587743
1781031979764280
1781031984304914

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQA42025-01-02
HIR22026-04-27

PMN#

GUDID#