This company has registrations in United States, Brazil, Canada, Taiwan, Russia — 5 overseas markets. The China NMPA lookup is still pending.
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 | K231856 | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) | 2024-03-15 |
| US | K172095 | Autokeeper | 2018-07-24 |
| US | K152410 | Top Fine Pen Needle | 2016-02-02 |
| BR | 80117580689 | Safety Pen Needle | Class II |
| BR | 80117580484 | Insulin Pen Needle (Agulha para caneta de insulina) | Class II |
| CA | 71678 | LATEX MEDICAL EXAMINATION GLOVES, LIGHTLY POWDERED, DERMAFIT | Class II |
| CA | 71679 | VINYL MEDICAL EXAMINATION GLOVES, LIGHTLY POWDERED, DERMAFIT | Class II |
| CA | 72250 | DERMAFIT MEDICAL LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE | Class II |