Smartdata Suzhou Co., Ltd
Suzhou Jiangsu, CN
SMARTDATA SUZHOU CO., LTD appears in FDA device records in Suzhou Jiangsu, CN. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Smartdata Suzhou Co., Ltd between 2018 and 2019. The busiest year on record is 2019, with 3. The most recent is 2019, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2019 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K191366 | Vacutore Air/Water Bottle Tubing | OCX | Substantially Equivalent | |
| K191231 | Andorate Auxiliary Water Connector, Andorate Valves Set | ODC | Substantially Equivalent | |
| K182998 | Andorate Auxiliary Water Connector | OCX | Substantially Equivalent | |
| K181509 | Endorate Valve Sets | OCX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008058134 | 3008058134 | SMARTDATA SUZHOU CO., LTD | F4, Building 7, 198 Jinshan Rd, Suzhou Jiangsu 215011 CN | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
- CBCBottle, Collection And Trap, Breathing System (Uncalibrated)
- KTIBronchoscope Accessory
- ODCEndoscope Channel Accessory
- MNKEndoscopic Bite Block
- OCXEndoscopic Irrigation/Suction System
- OCUEndoscopic Storage Cover
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope
- HMPPad, Eye
- NKCTubing/Tubing With Filter, Insufflation, Laparoscopic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain