FDA.reportPublic FDA data

ZHUHAI

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
ZHUHAI WESEE MEDITECH CO., LTD5N2026-01-013-301, 178 Dingxing Road, Tangjiawan Town, Hitech Zone Zhuhai Guangdong CN 519085
30117122513011712251ZHUHAI JIANLANG DAILY NECESSITIES CO., LTD.1N2026-01-01Factory No.3, No.33 Jinsui Road, Hongqi Town, Jinwan District Zhuhai Guangdong CN 519000
30122059303012205930ZHUHAI CRYSTAL DENTAL TECHNOLOGY CO.,LTD1N2026-01-013F, extension building, No.6 Ivyuan Rd, Nanping Science and Tech Zhuhai Guangdong CN 519000
30136874683013687468ZHUHAI PUSEN MEDICAL TECHNOLOGY CO, LTD1N2026-01-011F and 5/F, Building 1 and 3, No 33, Keji San Road, High-tech Zo Zhuhai Guangdong CN 519085
30220878603022087860ZHUHAI MJ DENTAL LABORATORY1N2026-01-01Zone B, 2nd Floor, No.5, Pingdong 1st Road, Nanping Technology, Zhuhai Guangdong CN 519000
30225918193022591819ZHUHAI NINUO BIOLOGICAL TECHNOLOGY CO.,LTD1N2026-01-01603-2, 1100 Jinzhou Road, Tangjiawan Town High-tech Zone Zhuhai Guangdong CN 519090
30305194883030519488ZHUHAI FITLENS MEDICAL TECHNOLOGY CO., LTD1N2026-01-01Room 101, Building 6, No. 129, Dingxing Road, Tangjiawan Town, H Zhuhai Guangdong CN 519000
30327231363032723136ZHUHAI NIRAY PHOTON TECHNOLOGY CO., LTD.1N2026-01-015F, Building 5, No.66, Keji 1st Road, Tangjiawan Town, High-tech Zone Zhuhai Guangdong CN 519080
30369786103036978610Zhuhai Pusen Medical Technology Co., Ltd.1N2026-01-01No. 1118, Jinrui Yi Road, High-tech Zone Zhuhai Guangdong CN 519085
00ZHUHAI HUAMU MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.5N2020-04-25Plant 101,No.12,Anji West Road,Sanzao Town,Jinwan District ZHUHAI Guangdong CN 215000
00ZHUHAI HAIOU MEDICAL EQUIPMENT CO., LTD5N2020-04-25Room 110, Floor 1, R&D Building, No. 1 Baisha Road, Tangjiawan T Zhuhai Guangdong CN 519080
00ZHUHAI KALI DEVELOPMENT CO. LTD.5N2020-04-255th Floor, Block 2, No.33 Yongnan Road, Xiangzhou Zhuhai Guangdong CN 519070
00ZHUHAI MEDHOPE TECHONLOGY CO.,LTD.5N2020-04-25Room 202 A, Building No.3, Zhuhai Ceiec High-Tech Industrial Par zhuhai Guangdong CN 519080
00ZHUHAI CMK MEDICAL EQUIPMENT CO. , LTD.5N2020-04-25Floor 3, building B, 208 Qinshi industrial zone Sanzao town Zhuhai Guangdong CN 519040
00ZHUHAI GREENTOWN HUALI INDUSTRIAL CO., LTD.5N2020-04-25No. 611 Warwick Road, Building 4 Floor 2 Xiangzhou District Warwick Road Zhuhai City Guangdong CN 519075
00ZHUHAI TINDA BIOMEDICAL TECHNOLOGY CO., LTD5N2020-04-25Room 201, Zone H,2nd floor, Jinqiao Building, Jinhai Industrial Zhuhai Guangdong CN 528000
00ZHUHAI ZHIPUDA HEALTH TECHNOLOGY CO., LTD5N2020-04-252F,Building 2, No.3 Shuanglin East Road, Hongqi Town, Jinwan Dis ZhuHai Guangdong CN 519090
00ZHUHAI ZOWIE ELECTRONIC TECHNOLOGY CO. LTD.5N2020-04-25RM608 Chengfeng Building 362 Cuiqian Bei Road Zhuhai Guangdong CN 519070
30101656533010165653ZHUHAI GUOJIA NEW MATERIAL CO., LTD1N2020-04-25No. 697 West Airplane Road, Sanzao Zhuhai Guangdong CN 519040
30140154903014015490ZHUHAI YASHA MEDICAL INSTRUMENT CO.,LTD1N2020-04-25Floor 4, No. 45 Guangsheng Road, Guangsheng Industrial Zone, Nan Zhuhai Guangdong CN 519060
30155221003015522100ZHUHAI SHUANGYE ELECTRONIC TECHNOLOGY CO.,LTD.1N2020-04-252F-1, Building No.4,No.1 Xingrong Road, Sanzao Town, Jinwan Dist Zhuhai Guangdong CN 519040
30166213613016621361ZHUHAI QINGCHUNYU BIOTECHNOLOGY CO., LTD1N2020-04-254th floor, building 2, No.18, Honghui fifth road Hongqi Town, Jinwan District Zhuhai Guangdong CN 519090

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2092581855522431K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)FED2026-04-06
3370061855522431K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)FED2026-04-06
3498201312556069K253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)EOB2026-03-25
3370061320533116K233778Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)FGB2024-07-16
2092581320533116K233778Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)FGB2024-07-16
3370061393149939K223741Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)FBN2023-06-22
2092581393149939K223741Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)FBN2023-06-22
3370061520397361K222602Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)FAJ2022-09-26
2092581520397361K222602Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)FAJ2022-09-26
3370061213257234K190648Pusen Eview Medical Video Endoscope Image ProcessorFET2019-03-29
2092581213257234K190648Pusen Eview Medical Video Endoscope Image ProcessorFET2019-03-29
2092581143283470K172098Medical Video Endoscope SystemFGB2017-08-31
3370061143283470K172098Medical Video Endoscope SystemFGB2017-08-31
2092581043371314K171076Medical Video Endoscope SystemFGB2017-05-05
2524311536711980K102096POWDER FREE NITRILE EXAMINATION GLOVES, BLUELZA2010-10-04
2572951023532983
2513021086144345
2455151086467158
2513021090562763
2575071151887687
2513021159643656
2342921167811517
2304521171813463
2513021174192951
2513021222469940
2395031226952190
2513021245361064
2554991261905838
2575071314562003
2513021394893686
2513021403685782
2513021556158996
2524311562914576
2569951564385248
2513021598333703
2493671626125896
2554991710997618
2569951747571121
2445841767496194
2513021805077271
2575071845785173
2575071872878327
2513021874664219
2118061877783546
2554991926345879
2513022000746678
3032401046456302
1873791095693526
3032401212294112
3032401235187439
3246031313203769
1873791318780102
1873791327567397
1873791382674285
1873791384744814
1873791388344997
3045481389044923
3032401397390769
1873791453313083
1873791464436314
3352771486416963
3032401560701633
1873791571058467
1873791577287587
3352771585137215
3352771638488418
1873791677499220
3370061695128455
2092581695128455
3032401783308495
3352771786000444
1873791804256594
1873791830750477
3452561876979597
3032401887227784
1873791913191186
1873791924457545
1873791944063629
3045481988146785
3498201992649453
3032402018438164
3370062063155651
2092582063155651

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FGB62024-07-16
FED22026-04-06
FBN22023-06-22
FAJ22022-09-26
FET22019-03-29
EOB12026-03-25
LZA12010-10-04

NDC#

BEIZRAY

Zhuhai Beihai Biotech Co., Ltd.

Docetaxel

BEIZRAY

Zhuhai Beihai Biotech Co., Ltd.

Docetaxel

PMN#

Dental Unit

2015-03-13

Zhuhai Siger Medical Equipment Co., Ltd

Applications#

GUDID#

Wesee - This is the video cable(model: CP11A), it is intended to be connected with the SP11A. The Disposable Video Rhinolaryngoscope SP11A is a sterile, single-use, flexible endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is used in conjunction with the Endoscopic Video Processor to provide the images. The SP11A is used to connect to the endoscopic video processor via the video cable CP11A. The endoscope is intended for use in a hospital environment. It is designed for use in adults.

Zhuhai Wesee Meditech Co., Ltd.

2026-04-13

Single Use Video Ureteroscope Direct In-Scope Suction - This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.This instrument is also used as a suction catheter that establishes a conduit used for irrigation and aspiration of kidney stones and stone dust during ureteral lithotripsy.This instrument is labeled Standard Deflection.

Zhuhai Pusen Medical Technology Co, Ltd

2026-01-13

Single Use Video Ureteroscope Direct In-Scope Suction - This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.This instrument is also used as a suction catheter that establishes a conduit used for irrigation and aspiration of kidney stones and stone dust during ureteral lithotripsy.This instrument is labeled Reverse Deflection.

Zhuhai Pusen Medical Technology Co, Ltd

2026-01-13

Single Use Video Ureteroscope Direct In-Scope Suction - This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.This instrument is also used as a suction catheter that establishes a conduit used for irrigation and aspiration of kidney stones and stone dust during ureteral lithotripsy.This instrument is labeled Standard Deflection.

Zhuhai Pusen Medical Technology Co, Ltd

2026-01-13

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