This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Singapore, South Korea, Australia, Israel, Russia — 10 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 |
|---|---|---|---|
| EU | 06941165018506 | Biopsy Guides | Class I |
| EU | 06941165064770 | Disposable Automatic Core Biopsy Instruments | Class IIa |
| EU | 06941165064763 | Disposable Automatic Core Biopsy Instruments | Class IIa |
| EU | 06941165064695 | Disposable Automatic Core Biopsy Instruments | Class IIa |
| UK | 35886 | Disposable Puncture Needles | Class IIa |
| UK | 44714 | Transducer Covers | Class IIa |
| UK | 44714 | Ultrasound Cover Kits | Class I |
| US | K212820 | Disposable Semi Automatic Biopsy Instrument | 2022-07-06 |
| US | K212819 | Disposable Biopsy Refill Needle | 2022-07-06 |
| US | K212822 | Disposable Coaxial Biopsy Needle | 2022-07-06 |
| BR | 80199950052 | Capa Protetora para equipamentos médicos | Class I |
| BR | 80199950053 | Cânula Endocavitária | Class I |
| BR | 80199950054 | Guia Reutilizável para Transdutor Endocavitário | Class I |
| SA | ME0000003131SFDAA00005 | Latex Ultrasound Probe Cover | — |