FDA.reportPublic FDA data

NANJING

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30085165483008516548NANJING SHUANGWEI BIOTECHNOLOGY CO., LTD.1N2026-01-01No.123, Huakang Road, Jiangbei New Area Nanjing Jiangsu CN 210000
30103998283010399828NANJING NIKON JIANGNAN OPTICAL INSTRUMENT CO., LTD.1N2026-01-01No.9, Hengda Road, Economic Technology Development Zone Nanjing Jiangsu CN 210000
30135229503013522950NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.1N2026-01-01666# Middle Zhengfang Road, Jiangning Nanjing Jiangsu CN 211111
30143833823014383382NANJING HI-TECH TAPE PRODUCTS CO. LTD.1N2026-01-01No.1 Zhushan Road, Gaochun Economic Development Zone Nanjing Jiangsu CN 211300
30151428023015142802NANJING ANJIAN MEDICAL DEVICE CO.,LTD.1N2026-01-01Building 9 No. 16 Xinggu Road Guli Street Jiangning District Nanjing Jiangsu CN 211100
30210112083021011208NANJING BESTVIEW LASER S&T CO.,LTD.1N2026-01-011st & 2nd Floor,Building 5,Liandong U Valley Science and Technol Nanjing Jiangsu CN 210000
30263174453026317445NANJING CHAMLION LASER TECHNOLOGY CO., LTD.1N2026-01-01Fengji Avenue 15, Building A02, Yuhuatai District, Nanjing city, Nanjing Jiangsu CN 210012
30357834423035783442NANJING TIANLANG PHARMACEUTICAL COMPANY LTD1N2026-01-01No. 8 Shuibao Road, Yongyang Town, Lishui District Nanjing City Jiangsu CN 210000
30398571143039857114NANJING KANGNI SMART TECHNOLOGY CO.,LTD.1N2026-01-01No.11 Hengjing Rd. Economic & Technological Development Zone Nanjing Jiangsu CN 21146
00NANJING LOVE QIN EDGE CLOTHING CO., LTD5N2020-04-25No.188 Wutai highway Edgeworthia town Gaochun county Nanjing Jiangsu CN 211303
00NANJING YVETTE SPORTS DEVELOPMENT CO.,LTD.5N2020-04-254-5 Floor, Building 3,No.68 Aoti Street,Jianye District Nanjing Jiangsu CN 210019
00NANJING RUNNA MEDICAL TECHNOLOGY CO.LTD5N2020-04-25GaoChun of Nanjing 35 XiuShan road NanJing Jiangsu CN 211300
00NANJING SENGONG BIOTECHNOLOGY CO., LTD.5N2020-04-25B8-201,NO.9 Kechuang Avenue,jiangbei new area Nanjing Jiangsu CN 210000
00NANJING SUNNY TECHNOLOGY CO.,LTD5N2020-04-25Room 1008,1,Wanda Plaza(West District),No68 Zhu Shan Road ,Dongs Jiangning District Nanjing Jiangsu CN 211100
00NANJING SUNRISE TRADING CO., LTD5N2020-04-25Room1304, ZhongHai Mansion, NO.39 Qingliangmen street, Gulou dis Nanjing Jiangsu CN 310000
00NANJING YAOKE MEDICAL EQUIPMENT CO., LTD5N2020-04-25Floor 1, Building C5, No.9, Kechuang Avenue Zhongshan Science Park, Jiangbei New District Nanjing Jiangsu CN 210008
00NANJING YITEBO MEDICINE SCIENCE AND TECHNOLOGY DEVELOPMENT C5N2020-04-25Building 72, 420 Wangxin Road Zhongshan Science and Technology Park, Liuhe Dis Nanjing Jiangsu CN 211500
00NANJING KANGQIAN PROTECTIVE EQUIPMENT CO.,LTD5N2020-04-25No.129Suyuan Avenue,Molin Street,Jiangning District,Nanjing City Nanjing Jiangsu CN 210000
00NANJING BLUER ENVIRONMENTAL SCI-TECH CO. LTD.5N2020-04-25Building 4, Yuhao research&industrial park , Pukou Economic Deve Nanjing Jiangsu CN 211800
00NANJING DERUNHONG GARMENTS CO., LTD.5N2020-04-25NO. 15, PUSI ROAD, JIANGBEI NEW DISTRICT Nanjing Jiangsu CN 210032
00NANJING EXTMED THIRD PARTY LOGISTICS FOR MEDICAL CO.,LTD5N2020-04-25No.9 Cangxi Rd,Gaochun Economic Development Zone ,Nanjing nanjing Jiangsu CN 210000
00NANJING GLORY EMPIRE BIOTECHNOLOGY CO.,LTD5N2020-04-25NO.32 HUASHAN ROAD GAOCHUN ECONOMIC DEVELOPMENT ZONE NANJING CITY Jiangsu CN 211300
00NANJING HENGRUN HONGSU IMPORT & EXP CO. , LTD.5N2020-04-2523F-24F,LONG SHENG MANSION NO.30 HONGWU ROAD Nanjing Jiangsu CN 210000
00NANJING JIUXIAO PHARMACEUTICAL CO., LTD.5N2020-04-25No. 28 Kexin Road, Jiangbei New Area, Nanjing nanjing Jiangsu CN 210000
30108720863010872086NANJING JIN BAI HE MEDICAL APPARATUS CO., LTD.1N2020-04-2512, Wuge Rd, Jiangning, Nanjing City, Jiangsu 211113, China Nanjing Jiangsu CN 211106

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3115091947211955K260974CO2 Laser Machine (Monica-I,Monica-II)GEX2026-05-07
3115091760430689K260153Q-Switched Nd: YAG Laser System (Glamor Q)GEX2026-04-20
3453691142783437K252502Folding Mobility Scooter (KD101)INI2025-10-06
3453691057036758K252494Electrically powered wheelchair (KZ301B)ITI2025-12-05
3115091259982632K251919Thulium Laser System (Deluxlase)GEX2025-09-26
3115091381821236K250465CO2 Laser Machine (Lume)GEX2025-06-09
3115091137137088K242440Intense Pulsed Light Treatment System (LK-PT)ONF2024-11-14
3115091054164793K211735CO2 Laser Machine, Model: BW-203BGEX2021-10-22
3115091584474320K211335Diode Laser Machine, Model Number: BM-100GEX2021-07-28
2254581605754094K202570Insulin Syringe, Insulin Syringe with Safety RetractableMEG2021-07-02
2254581124751985K183665Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single UseMEG2019-09-06
2254581351623313K181478Roosin Xeroform Petrolatum DressingFRO2019-09-13
2254581691951556K181315Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressingFRO2019-02-14
1700171220338772K170787Powered Wheelchair DYW30A(D09)ITI2017-08-09
2254581236242980K170077LUOFUCON Silicone Ag Foam Dressing with BorderFRO2017-03-30
2254581517073447K143335Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)FRO2015-06-01
2254581118659827K142563Well Lead PVC Urethral CatheterEZD2014-10-28
2254581024418213K140954LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSINGFRO2015-03-23
2254581094618335K130908DISPOSABLE SILICONE FOLEY CATHETEREZL2013-10-03
2254581208173575K120181LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MMFRO2013-02-14
2254581773434231K112110STERILE LUBRICATING JELLYKMJ2012-04-10
2254581761052400K111405BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,GBM2012-02-13
2254581067331976K082815WELL LEAD SILICONE AND LATEX FOLEY CATHETERSEZL2008-10-08
2254581887592825K030712AMSURE URETHRAL CATHETERIZATION TRAYFCM2003-05-23
2254581174757023K030664AMSURE FOLEY INSERTION TRAYFCM2003-05-23
2404351050154437
2404351061865726
2404351125189810
2558841150963141
2598031163967773
2480801188453400
2488111205904131
2254581271852822
2215461279585611
2404351291456104
1700171306694885
2215461312384036
2512411317534046
2512411321937002
2480801343024202
2543051372200500
2418381421402629
2404351436908232
2474891482883109
2490721516287412
2494501528940175
2558841531969955
2215461534443891
2404351546702019
2470331613915133
2583431621715967
2512411669399059
2404351676412704
1700171680486755
2494501692677764
2515541709015074
2418381734035416
2494501754366448
2215461800486546
1700171841631871
2459931865712301
2490721884471494
2583431931570448
2215461934147046
1700171939461567
2470331958320122
2480801958546653
2488111973733279
1700172039863670
1700172060913245
3132641043607232
2254581063914846
2254581111553166
2254581186742455
1590891255822010
3132641294468866
2175601312447433
2254581380613575
2175601417979774
3132641431778782
2175601437613620
2254581454376181
3132641521209267
2254581542754760
2175601590938941
2254581594122820
2254581679406869
2175601681991268
2175601738929272
3132641743660306
2254581756084306
2254581778606629
2175601807823277
3132641839874134
1590891892911824
2175601897384357
2254581898056615
3353541929765163
3476761950964058
3132642002598109
1590892004326438
2254582057096407
1590892058772445

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX62026-05-07
FRO62019-09-13
ITI22025-12-05
MEG22021-07-02
EZL22013-10-03
FCM22003-05-23
INI12025-10-06
ONF12024-11-14
EZD12014-10-28
KMJ12012-04-10
GBM12012-02-13

NDC#

QAMZOVA

Nanjing Delova Biotech Co., Ltd.

Meloxicam

Lidocaine

Nanjing Chengong Pharmaceutical Co., Ltd.

Lidocaine

Lidocaine

Nanjing Chengong Pharmaceutical Co., Ltd.

Lidocaine

Arme Scar Gel

Nanjing Ludejin Corporation Management Co., Ltd

DIMETHICONE

PMN#

43 records. Showing 1-40. Next

Applications#

GUDID#

80 records. Showing 1-40. Next