International safety notice
This product was originally classified as Class II, with the general name of the target product being "non-active treatment device for single-use endoscopes for artificial openings". It is necessary to obtain certification as a medical device. ” and was registered as a Class I medical device. I did it.
Japan / PMDA Recalls · JPN · Mar 25, 2022
Key facts
| Title | This product was originally classified as Class II, with the general name of the target product being "non-active treatment device for single-use endoscopes for artificial openings". It is necessary to obtain certification as a medical device. ” and was registered as a Class I medical device. I did it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use endoscopic non-active treatment device for natural opening Brand name: Disposable biopsy forceps FB-32D |
| Manufacturer | Olympus Medical Systems Co., Ltd. |
| Date | Mar 25, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1