FDA Registration
Active
🇨🇳 China
EX031-DB9, EX032, EX033, EX033-M, EX033-X, EX035, EX036, EX037, EX037B, EX038, EX039, EX040, EX041-OXI, EX041, EX041B,
Reg #: 3033842401
·
FEI: 3033842401
·
Expires 2025
Products
1
Proprietary Names
36
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHENZHEN GREATMADE TECH LIMITED
- Registration Number
- 3033842401
- FEI Number
- 3033842401
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 604-1, 6th Floor, Henghe International Building, No.1 Donghuan road, Jinglong Community,, Longhua Street, Longhua District
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Shenzhen Greatmade Tech limited
- Operator Number
- 10091633
- Address
- 604-1, 6th Floor, Henghe International Building, No.1 Donghuan road, Jinglong Community,, Longhua Street, Longhua District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518000
- Country
- CN
- Correspondent
- Hanzhi Zhang
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2024-10-20 |
Proprietary Names
EX031-DB9, EX032, EX033, EX033-M, EX033-X, EX035, EX036, EX037, EX037B, EX038, EX039, EX040, EX041-OXI, EX041, EX041B,
IBP027D, IBP027E, IBP028A, IBP028B, IBP028C, IBP028D, IBP028E, IBP029A, IBP030A, IBP030C, IBP031A, IBP033, IBP034A,
EX074-OXI, EX075, EX076, EX077, EX078, EX078-BR, EX079, EX080-5S, EX081, EX082, EX083, EX084, EX085, EX086, EX087,
EX052-S, EX052-OXI, EX053, EX054, EX055, EX056, EX057-M, EX058, EX059A, EX060, EX060B, EX061, EX062, EX062B, EX063,
EX109, EX121, EX122, EX123, EX124, EX125, EX126,EX127. TP013, TP013-3, TP013-5, TP014, TP014-5, TP014-4, TP014-3,
TP074, TP074P, TP075, TP075P, TP076, TP078, TP078P, TP079, TP079P, TP080, TP-OR-WA, TP-OR-GE, TP-OR-PRO, TP01-RQ-22.
EX021-1.5, EX021, EX021G, EX022, EX023, EX024, EX024 (3M), EX024L, EX025, EX025-(3M), EX025-OXI, EX025-L, EX025-M,
CF005, CF005-6, CF005N, CF005C, CF005M, CF005-6, CF006, CF006N, CF006-H, CF006-A, CF006-1, CF007, CF007B, CF007C,
EX012, EX013, EX014, EX015, EX016, EX017, EX016-M, EX018, EX019, EX019-M, EX020B, EX020G, EX020G-1.5, EX020L, EX021-1.2,
IBP003F, IBP004A, IBP004B, IBP004C, IBP004D, IBP004E, IBP004F, IBP005A, IBP005B, IBP005C, IBP005D, IBP005E, IBP005F,
IBP034B, IBP035B, IBP036H, IBP037A, IBP038.TP001, TP002, TP001P, TP002P, TP001D, TP002D, TP002D-P, TP003, TP004, TP003P,
CF010, CF011, CF012, CF013, CF013B,CF016, CF016B, CF017, CF017B, CF017C, CF017H, CF018A, CF018B, CF018C, CF020, CF021,
EX063-M/B, EX064, EX065, EX066, EX067-M, EX069, EX070, EX070-N, EX070-N(3M), EX071, EX072, EX073, EX074-M,
TP014-3.5, TP015, TP015-1, TP015-3, TP015-3.5, TP015-4, TP015-5, TP015B, TP020-3, TP020, TP020-5, TP021, TP022, TP023,
TP053, TP053P, TP054, TP054P, TP055, TP055P, TP056, OEM-TP056P, OEM-TP057P, TP059P, TP061, TP062, TP063, TP064,
IBP024B, IBP024C, IBP024D, IBP024E, IBP025A, IBP025B, IBP025C, IBP025D, IBP025E, IBP026, IBP027A, IBP027B, IBP027C,
IBP021D, IBP021E, IBP022A, IBP022B, IBP022C, IBP022D, IBP022E, IBP023A, IBP023B, IBP023C, IBP023D, IBP023E, IBP024A,
IBP016D, IBP016E, IBP018A, IBP018B, IBP018C, IBP018D, IBP018E, IBP019A, IBP020B, IBP020C, IBP021A, IBP021B, IBP021C,
IBP011C, IBP011D, IBP011E, IBP012A, IBP012B, IBP012C, IBP012D, IBP012E, IBP013A, IBP013B, IBP013C, IBP013D, IBP013E,
TP029, TP030, TP032, TP032P, TP033, TP035, TP036, TP037, TP037-3.5, TP038, TP039, TP039P, TP040, TP040P, TP042, TP043,
IBP006A, IBP006B, IBP006C, IBP006D, IBP006E, IBP006F, IBP007A, IBP007B, IBP007C, IBP007D, IBP007E, IBP007F, IBP008A,
EX025-M6, EX026, EX026-TW, EX027, EX028, EX029, EX030, EX031, EX031-OXI, EX031-1, EX031-1.2, EX031-1.5, EX031-M,
TP064P, TP065, TP065P, TP066P, TP067P, TP068P, TP069P, TP070, TP070P, TP071, TP071P, TP072, TP073, TP072P, TP073P,
TP044, TP044P, TP045, TP045P, TP046, TP046P, TP047, TP047P, TP048, TP048P, TP049, TP049P, TP050, TP050P, TP051, TP051P,
TP024, TP025, TP025-3, TP025-5, TP026, TP031, TP031-Y, TP034, TP034-3, TP034-5, TP052, TP052-5
IBP014A, IBP014B, IBP014C, IBP014D, IBP014E, IBP015A, IBP015B, IBP015C, IBP015D, IBP015E, IBP016A, IBP016B, IBP016C,
EX088, EX090, EX091, EX093, EX094, EX095, EX097, EX098, EX099, EX100, EX101, EX102, EX103, EX105, EX106, EX107, EX108,
IBP008B, IBP008C, IBP008D, IBP008E, IBP009, IBP010A, IBP010B, IBP010C, IBP010D, IBP010E, IBP010F, IBP011A, IBP011B,
TP012, TP012-1.5, TP012-2, TP012P, TP016, TP016P, TP017, TP017P, TP018, TP019, TP019P, TP027, TP027P, TP028, TP028P,
EX042, EX043, EX044, EX044-3, EX045, EX046, EX047, EX048, EX048 (3M), EX048-3, EX049, EX050, EX051, EX052, EX052-M,
TP004P, TP005, TP006, TP005P, TP006P, TP007, TP007P, TP007P-1.5, TP008, TP008P, TP009, TP010, TP011, TP011-1.5, TP011P,
CF021B, CF022, IBP001A, IBP001B, IBP001C, IBP001D, IBP001E, IBP001F, IBP001G, IBP002A, IBP002B, IBP002C,
IBP002C-2-ED/ IBP002C-2, IBP002D, IBP002E, IBP002F, IBP002G, IBP002H, IBP003A, IBP003B, IBP003C, IBP003D, IBP003E,
EX001, EX001-D, EX002, EX003, EX004, EX005-1, EX005, EX005-3,EX006, EX007, EX008, EX008L, EX008-M, EX009, EX010, EX011,
Patient Adapter Cable
CF007K, CF007D, CF007D-L, CF007E, CF007F, CF007M, CF007H, CF007G, CF007N, CF007L, CF008, CF009, CF009B, CF009C, CF009-Y,
Establishment Types
Manufacture Medical Device