Smartdata Suzhou Co., Ltd.
Manufacturer and brand owner in Suzhou, Jiangsu, China. 11 device types, 4 products catalogued, 4 clearances.
Smartdata Suzhou Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Pad, Eye, Endoscopic Bite Block and 9 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2018.
11device types registered with the FDA
4products catalogued under its own name
4510(k) clearances
Registration
| Registered name | SMARTDATA SUZHOU CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008058134 |
| FEI number | 3008058134 |
| DUNS | 529507479 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | F4, Building 7, 198 Jinshan Rd |
| Postal code | 215011 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | Class 1 | Andorate | 2026 | 43 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | Class 1 | andorate | 2019 | 6 |
| Bottle, Collection And Trap, Breathing System (Uncalibrated) | Class 2 | Andorate | 2026 | 2 |
| Bronchoscope Accessory | Class 2 | Andorate | 2023 | 5 |
| Endoscope Channel Accessory | Class 2 | Andorate | 2018 | 21 |
| Endoscopic Bite Block | Class 1 | Andorate | 2018 | 44 |
| Endoscopic Irrigation/Suction System | Class 2 | Andorate, Vacutore | 2018 | 10 |
| Endoscopic Storage Cover | Class 2 | andorate | 2021 | 1 |
| Insufflator, Automatic Carbon-Dioxide For Endoscope | Class 2 | andorate | 2020 | 5 |
| Pad, Eye | Class 1 | Andorate | 2026 | 100 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | Class 1 | andorate | 2019 | 12 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K191366 | 2019-09-06 | OCX | Traditional | This company |
| K191231 | 2019-06-07 | ODC | Traditional | This company |
| K182998 | 2019-04-17 | OCX | Traditional | This company |
| K181509 | 2018-07-06 | OCX | Traditional | This company |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.