FDA.reportPublic FDA data

BEIJING

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
BEIJING SANHE LASER CO., LTD.5N2026-01-01Room 211, 2nd Floor, 101, Building 7, No. 1 Courtyard, Caida Thi Beijing CN 101300
30046455123004645512BEIJING SMART TECHNOLOGY CO., LTD.1N2026-01-01Room 401, Block C, Lvhai Tower, 2 Yongcheng North Road Beijing CN 100094
30054506043005450604BEIJING GENESEE BIOTECH, INC.1N2026-01-01No. 36, Yanqi Donger Road Huairou Yanqi Industrial Development Zone BEIJING CN 101407
30055699273005569927BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.1N2026-01-01No.9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District BEIJING CN 100041
30064001133006400113Beijing Beishute Maternity & Child Articles Co., Ltd.1N2026-01-01No. 3 Yuanguang Street Miyun District BEIJING CN 101500
30065556173006555617BEIJING SINCOHEREN SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD1N2026-01-011-23, 10th Floor, Building 1, No.43 Xizhimen North Street, Haidi Bejing Beijing CN 100044
30066672123006667212BEIJING TECH INSTRUMENT CO., LTD.1N2026-01-0111 Taoyang Road Yongwai Chongwen District Beijing CN 100075
30075835543007583554Beijing Taikesiman Technology Development Co., LTD1N2026-01-015 Li qiao duan, Li Tian Rd. Li Qiao Beijing CN 101304
30081912763008191276BEIJING RUICHENG MEDICAL SUPPLIES CO., LTD.1N2026-01-01Building 5, No. 8, Yanqi West Road, Yanqi Economic Development Z Beijing CN 101407
30085705473008570547BEIJING RONGRUI CENTURY SCIENCE TECHNOLOGY CO.,LTD1N2026-01-013rd Floor, West zone,No.1 Building,No.7 Yard Fengxian Middle Road,Haidian District Beijing CN 100094
30094888343009488834BEIJING HONKON TECHNOLOGIES CO., LTD.1N2026-01-01No.72 building, No.16 Huanke Middle Rd Tongzhou District Beijing CN 100176
30101413073010141307BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.1N2026-01-01A13-7, Jingshengnansi Street, 101102 Beijing, P. R. China Beijing CN 101102
30101990223010199022BEIJING HONGYISIFANG RADIATION TECHNOLOGY CORP., LTD.1N2026-01-01No. 18 Guangli Street Tongzhou Industrial Park Bejing Beijing CN 101113
30115644313011564431Beijing Target Medical Technologies Inc.1N2026-01-01No.60, Shunren Rd., Shunyi District Beijing CN 101300
30118985603011898560BEIJING HONGDEE CORPORATION1N2026-01-01Suite 402, Bldg No 7 Jingshengzhongjie, No 15 Beijing CN 100121
30127332313012733231BEIJING KINGST COMMERCIAL & TRADE CO., LTD.1N2026-01-015/F, Building 3, No.27, Yongwang Road Z-park Daxing Bio-medicine Industry Park, Dist. Beijing CN 102600
30138430553013843055BEIJING AK MEDICAL CO, LTD1N2026-01-01No.5 Wen an Street Changping District Beijing CN 102299
30146202013014620201BEIJING ZKSK TECHNOLOGY CO., LTD.1N2026-01-01Building 9, 6 & No.6 Yuan Hengye North 7th street, Yongle Econom beijing CN 101105
30154526933015452693BEIJING WINKONLASER TECHNOLOGY LIMITED1N2026-01-01No.28,Hegezhuang,Xiji Town,Tongzhou Dist. Beijing CN 101108
30166684513016668451BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD1N2026-01-011-2F Building 1&2,No.29 Yongda Road,Daxing Bio-medicine Industry Beijing CN 102600
30171244333017124433Beijing Nubway S&T Co.,Ltd.1N2026-01-01202, No.5 workshop, No.1 caida 3rd Road Nancai Shunyi District, Beijing CN 101300
30171328753017132875BEIJING SPIRITLASER SCIENCE & TECHNOLOGY CO., LTD.1N2026-01-012-813, Floor 8, Building 1, Yard 56, Fuqian Street Beijing CN 101300
30171735243017173524BEIJING SANHE TECH CO., LTD.1N2026-01-01Room 7-204, No.1, Caida 3rd Street, Nancai Town, Shunyi District Beijing CN 101300
30172009753017200975BEIJING SUPERLASER TECHNOLOGY CO., LTD.1N2026-01-011st Floor, Building 3, No.2 Zhongfu Street, Economic and Technol Xihongmen Town, Daxing District Beijing CN 100076
30195590903019559090BEIJING HUACHENG TAIKE TECHNOLOGY CO., LTD.1N2026-01-01Room 402, 4th Floor, Building 4, Courtyard 5, South Third Street 101113Beijing,P.R.China Beijing CN 101113

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3515211038150469K260690LumiGlam Laser System (SHE-LSP601-3)GEX2026-06-04
263382024608787K252268V series portable oxygen concentrator (V5, V5C, V6, V6C)CAW2025-12-16
2726221673150466K251457Diode laser therapy device (VADER)GEX2025-09-03
3123161421738092K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)GEX2025-06-12
3515211817754643K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)GEX2025-06-12
1210571284406806K242986SpO2 Extension CableDSA2025-05-02
2701322022764029K242951Diode laser hair removal machine (QDTM-02)GEX2025-04-28
2701321972248657K242943Q Switched Nd:YAG Laser machine (QNHF-01)GEX2025-03-03
3515211560280203K242941CO2 Laser Therapy Systems (SHE-LSP003-1)GEX2025-01-27
3123161857451099K242941CO2 Laser Therapy Systems (SHE-LSP003-1)GEX2025-01-27
1811741507341525K242248Introducer Sheath KitsDYB2024-08-22
2427581442321306K242192Disposable SphincterotomeKNS2025-02-06
3098271406066203K241860Diode Laser Hair Removal SystemGEX2024-09-25
3123161668840061K233416Cryojet Plus (SHE-ACP001-1)GEX2024-02-06
3515211921618964K233416Cryojet Plus (SHE-ACP001-1)GEX2024-02-06
3098271692968819K233007Picosecond Nd:YAG Laser System; PICO LEGENDGEX2024-06-12
263381983155581K232975Pulse Oximeter (MD300C228)DQA2024-06-21
1565451461981805K231894LED Spectrum therapy instrumentGEX2023-09-20
1565452040560070K231749Radio Frequency SystemGEI2023-10-19
2427582005043888K231721Disposable Hot Biopsy ForcepsKGE2023-12-14
2396521126928048K231513Oral MatrixNPL2024-02-16
263381933095792K230587Wrist Pulse OximeterDQA2023-11-30
263381527482660K230172Pulse OximeterDQA2023-08-12
3123161613431007K230024HI-EMT MAGSHAPENGX2023-09-06
3515211762335458K230024HI-EMT MAGSHAPENGX2023-09-06
1120651666750168K222408Disposable Safety LancetFMK2022-11-29
1210571097774767K222370SpO2 Extension CableDSA2023-04-02
1811741765729232K222184Introducer Sheath KitsDYB2023-02-21
1811741538141002K222182Radial Artery Compression TourniquetsDXC2023-01-04
1120651866923339K222034RightLance Blood Lancing SystemQRL2022-09-07
263381875128979K221992Electronic Pulse StimulatorNUH2022-10-21
3098271215862413K221246IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)OHT2022-07-07
263381188213683K220101Pulse OximeterDQA2023-03-08
2427581212918579K213239Endoscopic Injection NeedleFBK2022-06-02
2427582001432523K213223Multi-Band LigatorFHN2022-06-06
2427581098658796K213222Disposable Polypectomy SnareFDI2022-06-06
2427581475505252K213217Disposable hemoclipPKL2022-11-14
263381154294368K213189Wrist-type Fully Automatic Digital Blood Pressure MonitorDXN2022-03-01
263381501994909K211754Vital Signs MonitorMWI2021-11-15
263381450972324K211752Infrared ThermometerFLL2022-01-21
263381567494666K211400Pulse OximeterDQA2022-02-11
3279231380136873K210663Dermatological Diode Laser SystemsGEX2021-04-26
2396521603899957K201641Disposable Laparoscope TrocarGCJ2020-08-06
2396521601558975K201639Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and ReloadsGDW2021-05-27
2726221915143759K200042CO2 Laser SystemGEX2020-06-09
263381891312729K193627Automatic Upper Arm Blood Pressure MonitorDXN2020-07-12
2701321792529956K193609Q Switched Nd: YAG Laser machineGEX2020-03-20
2726221517104625K193464ND:YAG LaserGEX2020-04-13
2701321820315858K192735Diode Laser Hair Removal MachineGEX2020-04-03
2726221006438252K192519Multi-modality workstationONF2019-11-27
2726221412790409K192516Diode Laser 808nmGEX2019-12-10
2028161591430834K192488CO2 Sidestream ModuleCCK2020-05-22
2028162015094609K192446CO2 Mainstream ModuleCCK2020-05-21
3515211070795076K191970Diode Laser Hair Removal SystemGEX2020-04-06
3123161849178269K191970Diode Laser Hair Removal SystemGEX2020-04-06
3098271212484956K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemGEX2018-11-30
263381448123488K181503Fingertip Pulse OximeterDQA2018-10-11
263381938512148K181104Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm StyleDXN2018-08-29
2251021733880451K180493A3 Total Knee SystemJWH2018-06-22
263381059451938K173024Non-invasive blood pressure measurement systemsDXN2018-08-22
263381905667205K172895AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819DXN2018-06-18
263381720576699K172366Wrist Pulse OximeterDQA2018-03-16
263381518868117K171833Digital Blood Pressure Monitor-Wrist StyleDXN2018-01-10
263381331639097K170666The Wrist-Type Fully Automatic Digital Blood Pressure MonitorsDXN2017-11-22
1565452016189311K163123Q-Switched Nd:YAG Laser Therapy SystemsGEX2017-02-02
263381385687003K162517Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13NUH2017-04-14
1565451353669965K162398CO2 Laser Therapy SystemsONG2017-07-06
3098271461909217K162169EdgeOne CO2 LaserGEX2016-10-27
263381267895777K162089Blood Pressure MonitorDXN2017-02-10
263381460039817K162083RII Multi-function Infrared Thermometer, Model TH52ZFLL2017-01-09
1637781119390721K161892Slimming Treatment DeviceNUV2017-03-02
263381434910994K161560Fingertip Pulse Oximeter MD300CN310DQA2016-10-05
263381023584520K160802Infrared Forehead Thermometer, FT-100AFLL2016-08-24
263381118143557K160508Electronic Pulse StimulatorNUH2016-11-21
263381505427126K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51DQA2016-10-14
973431668640619K160130BloodSTOP iX Battle MatrixQSY2016-06-29
263381022784503K153520Electronic Pulse StimulatorNUH2016-05-05
1565451669068159K152898DIODE LASER THERAPY SYSTEMSGEX2016-02-09
263381074845237K152563Pulse Oximeter (MD300M/MD300K2)DQA2016-04-18
263381618024524K151206Fingertip Pulse OximeterDQA2015-08-28
263381234954132K150430Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorDXN2015-04-17
263382025923158K142888Fingertip Pulse OximeterDQA2015-02-20
1811741749455798K140943MASTRO PLUS BALLOON IN-DEFLATION DEVICEMAV2015-03-05
263381372620645K140682FINGERTIP PULSE OXIMETERDQA2014-07-17
263381773364251K132588ADHESIVE ELECTRODESGXY2013-11-22
263381459055379K132085ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAMLCX2013-11-12
263381309479606K131921ELECTRONIC PULSE STIMULATORNUH2013-11-15
1637781343609363K131859MULTIFUNCTIONAL SERIESONF2013-10-18
1637781573622659K131857Q-SWITCHED ND:YAG LASERGEX2014-01-16
1637781267325234K131838DIODE LASER FOR HIAR REMOVALGEX2014-04-24
1637781897178248K131837CO2 FRACTIONAL LASERGEX2014-01-22
263381003888495K131457FETAL ULTRASONIC MONITOR AND ACCESSORIESKNG2014-01-24
263381938563061K131395TRANSTEK BLOOD PRESSURE MONITORDXN2013-06-19
263381055571399K131243NON-CONTACT INFRARED THERMOMETERFLL2013-11-12
263381599956171K131047FINGERTIP PULSE OXIMETERDQA2013-10-16
263382054555546K130947FINGERTIP PULSE OXIMETERDQA2013-10-03
263381485281715K123882AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITORDXN2013-08-14
263382059622252K123871FINGERTIP PULSE OXIMETERDQA2013-05-10
1785881797169282K123475SHOOCIN INTRODUCER KITDYB2014-02-03
1565451994344128K123435IPL THERAPY SYSTEMONF2013-02-11
263381260876501K122046WRIST PULSE OXIMETERDQA2013-02-04
263381903773876K120554ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITORDXN2012-08-10
263381502935851K112911FETAL DOPPLERKNG2011-10-27
263381842264199K112622HANDHELD ECG MONITORDPS2012-07-19
1785881565506637K111837RADIAL ARTERY COMPRESSION TOURNIQUETDXC2011-09-27
263381039828000K110721GAUNYING INFRARED LAMPILY2011-03-30
1210571586192395K103685PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CADQA2011-07-15
263381482086653K101577MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIESDQA2010-12-02
263381471951012K100740MD2000B VITAL SIGN MONITOR, MODEL MD2000BMWI2010-07-09
1897981085580912K100439MEDIWORKS SLIT LAMPHJO2010-07-16
263381842053674K100203HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300MDQA2010-05-17
263381644167945K093872HANDHELD ECG MONITOR, MODEL MD100DPS2010-03-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX312026-06-04
DQA312024-06-21
DXN122022-03-01
NUH52022-10-21
FLL52022-01-21
ONF42019-11-27
DSA32025-05-02
DYB32024-08-22
QSY32016-06-29
DPS32012-07-19
NGX22023-09-06
DXC22023-01-04
MWI22021-11-15
CCK22020-05-22
NUV22017-03-02
KNG22014-01-24
LCX22013-11-12
HEX22007-11-15
CAW12025-12-16
KNS12025-02-06
NPL12024-02-16
KGE12023-12-14
GEI12023-10-19
FMK12022-11-29
PKL12022-11-14
QRL12022-09-07
OHT12022-07-07
FDI12022-06-06
FHN12022-06-06
FBK12022-06-02
GDW12021-05-27
GCJ12020-08-06
JWH12018-06-22
ONG12017-07-06
MAV12015-03-05
GXY12013-11-22
ILY12011-03-30
HJO12010-07-16
GZJ12003-12-10
BTI12003-10-07

NDC#

Gen7T Plus

Beijing HKKY Medical Tech. Co., Ltd.

Lidocaine, Menthol

NOAVIA Retinol Moisturizer

Beijing JUNGE Technology Co., Ltd.

CAFFEINE,ASCORBIC ACID,TOCOPHEROL,RETINOL,HYDROLYZED COLLAGEN,Vitamin A

PMN#

Oral Matrix

2024-02-16

Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

Pulse Oximeter

2023-08-12

Beijing Choice Electronic Technology Co., Ltd.

Pulse Oximeter

2023-03-08

Beijing Choice Electronic Technology Co., Ltd.

169 records. Showing 1-40. Next

Applications#

211339

BEIJING SL PHARMA CO LTD

209947

BEIJING TIDE PHARMA CO LTD

GUDID#

AquafirmeXS

Beijing Anchorfree Technology Co., Ltd.

2025-09-23

80 records. Showing 1-40. Next