This company has registrations in European Union, United States, United Kingdom, Canada — 4 overseas markets. EU UDI-DI records ≥259, the first 300 verified individually. No China NMPA registrations were found.
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.
Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| EU | 04961333252121 | PENTAX Medical Gas/Water Feeding Valve OE-B14 | Class IIa |
| EU | 04961333252039 | PENTAX Medical Video Duodenoscope ED34-i10cT | Class IIa |
| EU | 04961333252077 | PENTAX Medical Video Duodenoscope ED34-i10cT2 | Class IIa |
| EU | 04961333247950 | PENTAX Medical Video Processor EPK-i8020c | Class IIa |
| UK | 64376 | PENTAX Medical R/L Assistant Knob | Class I |
| UK | 47143 | PENTAX Electro diathermy system electrode | Class IIb |
| UK | 61792 | Pentax Endoscope assembly adapter | Class IIa |
| US | K192280 | PENTAX Medical ED-3490TK Video Duodenoscope | 2019-10-21 |
| US | K171011 | PENTAX Medical VIVIDEO ENT Videoscope Solution | 2018-07-18 |
| US | K172156 | PENTAX Medical EPK-3000 Video Imaging System | 2018-04-05 |
| CA | 8848 | PENTAX SIGMOIDOSCOPE | Class II |
| CA | 9676 | CHOLEDOCHO/NEPHROSCOPE | Class II |
| CA | 9715 | PENTAX URETERO-RENOSCOPE | Class II |