This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 8 overseas markets. The China NMPA lookup is still pending.
Australia, Hong Kong, Singapore, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K203229 | NATRELLE INSPIRA Single Use Sizers for Gel Implants | 2021-06-02 |
| US | K193589 | TrueTear Intranasal Tear Neurostimulator | 2020-08-31 |
| US | K190674 | REFRESH RELIEVA For CONTACTS | 2019-08-08 |
| CA | 84856 | NATRELLE 150 BREAST IMPLANT | Class IV |
| CA | 84862 | BREAST PROSTHESIS FILL TUBE PLUG KIT | Class IV |
| CA | 101233 | NATRELLE 410 TRUFORM MICROCELL SILICONE-FILLED BREAST IMPLANTS | Class IV |
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