2023/6/6 Confirmation Page Help (./help/index.html) DRLM Home (mainMenu.htm) Change Registration Information for a Facility Facility Products Listing Update Registration Successful Facility: CHONGQING MOFFY INNOVATION TECHNOLOGY CO., LTD. , Chongqing , Chongqing, CHINA Registration/FEI Number: 3021235837/3021235837 The Owner/Operator Number for this Registration is: 10083174. Facility Information Registration Number: 3021235837 Initial Importer: N Facility Name: CHONGQING MOFFY INNOVATION TECHNOLOGY CO., LTD. Legal Name: Address: No.292 Jingdongfang Rd.Beibei Dist, Chongqing, Chongqing, 400714, CHINA DUNS Number: Foreign Trade Zone: N Facility URL: Other Business Trade Name(s): Establishment located on a campus: Owner/Operator Information Owner/Operator Number: 10083174 Contact Name: Yongxu Li Company: CHONGQING MOFFY INNOVATION TECHNOLOGY CO., LTD. Address: No.292 Jingdongfang Rd.Beibei Dist Chongqing, 400714, CHINA https://www.access.fda.gov/drlm/drlm.htm?_flowExecutionKey=_c1F128344-3976-D0F8-9483-0EC0B1D10B29_kC2951952-803E-C11C-8A55-041AC… 1/4 2023/6/6 Confirmation Page Telephone: 86 - 159 - 2768 - 6299 Fax: E-mail: inquirymed@hotmail.com DUNS Number: Official Correspondent Information Contact Name: Yongxu Li Company: CHONGQING MOFFY INNOVATION TECHNOLOGY CO., LTD. Address: No.292 Jingdongfang Rd.Beibei Dist Chongqing, 400714, CHINA Telephone: 86 - 159 - 2768 - 6299 Fax: E-mail: inquirymed@hotmail.com DUNS Number: United States Agent Information Contact First Name Leeyeo Contact Last Name Kee Contact Title: Ms Business Name: Regrek LLC Address: 19 Holly Cove Ln. Dover, Delaware, 19901, UNITED STATES Phone: 302 - 6089028 Fax: DUNS Number: E-mail: regrek.cs@hotmail.com Device Listings https://www.access.fda.gov/drlm/drlm.htm?_flowExecutionKey=_c1F128344-3976-D0F8-9483-0EC0B1D10B29_kC2951952-803E-C11C-8A55-041AC… 2/4 2023/6/6 Listing Number Confirmation Page Premarket Submission Number D480348 Premarket Submission Type Product Code(s) Device Name(s) Activities 510(k) exempt ISD Exerciser, measuring Foreign Exporter Importers Contract Manufacturer Manufacturer D480349 D463135 510(k) exempt K203196 KFZ BZH HUMIDIFIER, NONDIRECT PATIENT INTERFACE (HOMEUSE) Foreign Exporter METER, PEAK FLOW, SPIROMETRY Foreign Exporter Contract Manufacturer Manufacturer Manufacturer D455295 510(k) exempt KMA IRRIGATOR, POWERED NASAL Foreign Exporter Contract Manufacturer Manufacturer D455296 510(k) exempt ION EXERCISER, NONMEASURING Foreign Exporter Contract Manufacturer Manufacturer D455297 510(k) exempt BSY CATHETERS, SUCTION, TRACHEOBRONCHIAL Foreign Exporter Contract Manufacturer Manufacturer D455298 510(k) exempt KAR IRRIGATOR, SINUS Foreign Exporter Manufacturer Contract Manufacturer D505217 510(k) exempt GCX APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED Manufacturer Contract Manufacturer Foreign Exporter Date of Initial Registration: 2021-10-31 23:24:00.0 https://www.access.fda.gov/drlm/drlm.htm?_flowExecutionKey=_c1F128344-3976-D0F8-9483-0EC0B1D10B29_kC2951952-803E-C11C-8A55-041AC… 3/4 2023/6/6 Confirmation Page https://www.access.fda.gov/drlm/drlm.htm?_flowExecutionKey=_c1F128344-3976-D0F8-9483-0EC0B1D10B29_kC2951952-803E-C11C-8A55-041AC… 4/4