HSA · registration DE0507264FUJIFILM Diathermic Slitter, Flush Knife, Slim, DK2623JI
- Registration number
- DE0507264
- Model name
- DIATHERMIC SLITTER, FLUSH KNIFE, SLIM, DK2623JI; DIATHERMIC SLITTER, FLUSH KNIFE, SLIM, DK2623JI; DIATHERMIC SLITTER, FLUSH KNIFE, SLIM, DK2623JI; DIATHERMIC SLITTER, FLUSH KNIFE, SLIM, DK2623JI
- Model identifier
- DK2623JI -B15-; DK2623JI -B20-; DK2623JI -N15-; DK2623JI -N20-
- Registration date
- September 15, 2022
- Source update date
- September 09, 2025
- Risk class
- Class B
- Product owner
- Fujifilm Corporation
- Registrant / registration holder
- FUJIFILM HEALTHCARE ASIA PACIFIC PTE. LTD.
These products are intended to be used in combination with an endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, dissection, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to supply saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities.
- Product owner address
- 26-30, Nishiazabu 2-chome, Minato-ku, Tokyo 106-8620, Japan
- Registrant address
- 20 PASIR PANJANG ROAD, #08-21, MAPLETREE BUSINESS CITY, Singapore 117439
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.