FDA.report

ORANTECH INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30137834883013783488ORANTECH INC.1N2026-01-01Zone#A,4F,1st Bld,7th Industrial Zone,Yulv Community, GongMing, Shenzhen Guangdong CN 518106

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2230221228162216K823670E.S. PENCILGEI1983-01-12
2230221224589883K203620Aneroid SphygmomanometerDXQ2021-03-23
2230221728551329K182327Patient Cables and Leadwires , Disposable ECG LeadwiresDSA2019-01-30
2230221313246427K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsDQA2018-09-07
2230221110716161K173197Reusable NIBP CuffDXQ2018-08-21
2230221052693604K173194Temperature ProbeFLL2018-10-10
2230221198511076K171828ETCO2 SensorCCK2018-05-31
2230221532800432K152472Disposable Pressure TransducerDRS2016-10-31
2230221179458172K140535PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50HGM2014-11-25
2230221026133260K081951ANEROID SPHYGMOMANOMETER, MODEL KT-A01DXQ2008-08-15
2230221557026952K002384M-XX OXYGEN SENSORSCCL2000-12-15
2230221050266627
2230221054801396
2230221139752523
2230221270959048
2230221315285568
2230221352237688
2230221439998599
2230221500311477
2230221581961742
2230221617862018
2230221707782588
2230221770134420
2230221895830083
2230221908273894
2230222025237967
2230222035116678

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DXQ32021-03-23
DSA12019-01-30
FLL12018-10-10
DQA12018-09-07
CCK12018-05-31
DRS12016-10-31
HGM12014-11-25
CCL12000-12-15
GEI11983-01-12

PMN

GUDID

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