Certificates
Registration Status
| Region | Certification | No. | Scope | |
|---|---|---|---|---|
| Global | ISO 13485:2016 | 10504-2017-AQ-KOR-NA-PS (DNV) | All products | ↗ |
| Korea | Manufacturing License | No. 1023 | All products (manufacturing) | ↗ |
| Korea | Import License | No. 3350 | Imported items | ↗ |
| Korea | KGMP | KTL-AABA-19238 (HQ) / KTL-ABBA-18970 (Yantai) | ESU Pencil, Smoke Pencil, Needle electrode | ↗ |
| Korea | Product approvals | See each certificate | All products | ↑ |
| EU | EU MDR QMS Certificate (DNV, NB 2460) | C611944 | Ground plates, electrosurgical pencils, smoke evacuation pencils (Class IIb) | ↗ |
| EU | CE Declaration of Conformity (MDR Class I) | ECG·TAB·Neonatal·TENS·EEG·EMG surface electrodes, Smoke Evacuation System | ||
| USA | FDA 510(k) Cleared (17) | K020003, K040784, K042301, K053011, K073360, K073438, K083148, K091248, K092732, K092761, K100246, K111270, K142099, K143103, K152984, K153019, K192035 | ECG·TAB·Neonatal·TENS electrodes, ESU Plate·Pencil, Smoke Pencil·Evacuator, EMG Needle, TENS·EMS·IF Unit | ↗ |
| USA | FDA Device Listing (510(k) exempt) | D370701, D531985 | Laparoscopic smoke evacuator, Smoke Tubing | |
| Japan | Foreign Manufacturer Registration | BG10300079 | HQ | ↗ |
| China | Production License (Yantai) | 鲁药监械生产许20230059号 | Active surgical, diagnostic & monitoring devices (Class II) | ↗ |
| China | NMPA Registration (Yantai) | 鲁械注准20262070303 | Disposable needle electrode | ↗ |
| China | NMPA Registration (Yantai) | 鲁械注准20262010229 | Electrosurgical electrode (Smoke Pencil · ESU Pencil) | ↗ |
※ For other countries and product availability by country, please contact our Sales team.