This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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 | K240763 | FirstFit Surgical Kit | 2024-12-18 |
| US | K192422 | Steerable Introducer 12F | 2019-10-04 |
| US | K191190 | Steerable Introducer | 2019-08-01 |
| BR | 81591120021 | Tampa com filtro de espuma HumidiFilter® ATSV II Blom Singer® | Class II |
| BR | 81591129002 | Válvula ajustável para traqueostoma ATSV II Blom Singer® | Class II |
| BR | 81591120018 | Protetores de espuma para estoma Blom Singer® | Class I |
| SA | ME0000009158SFDAA00001 | Shower Guard | — |
| SA | ME0000009158SFDAA00002 | TruSeal | — |
| CA | 6899 | BLOM SINGER INSUFFLATION TEST SET | Class II |
| CA | 8813 | BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS | Class II |
| CA | 9093 | BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET-STERILE | Class II |