SUNDEX CORPORATION
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008076203 | 3008076203 | SUNDEX CORPORATION | 1 | N | 2026-01-01 | 7F-3, No. 186, SEC. 4 Nanjing E. Rd Taipei TW 10595 |
| 3014299855 | 3014299855 | SUNDEX OPTICAL CO., LTD | 1 | N | 2026-01-01 | No.19 Yong Gong 2nd Road Yong An District Kaohsiung City TW 82841 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 144198 | 1448054659 | K170136 | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs | LZA | 2017-08-25 |
| 144198 | 1007024070 | ||||
| 144198 | 1079868684 | ||||
| 217321 | 1094056907 | ||||
| 217321 | 1107680997 | ||||
| 144198 | 1159300571 | ||||
| 144198 | 1271544500 | ||||
| 144198 | 1314029980 | ||||
| 144198 | 1329867842 | ||||
| 144198 | 1380160818 | ||||
| 217321 | 1539356011 | ||||
| 144198 | 1740962509 | ||||
| 144198 | 1794478251 | ||||
| 144198 | 1930200899 | ||||
| 144198 | 1967672447 | ||||
| 144198 | 2004003537 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LZA | 1 | 2017-08-25 |