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Singapore HSA registration DE0507264

FUJIFILM Diathermic Slitter, Flush Knife, Slim, DK2623JI

Singapore flagSingapore·CLASS B·Fujifilm Corporation·Registered September 15, 2022
Device classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0507264
Registration Date
September 15, 2022
Change Notification Approval Date
March 22, 2024
Retention Due Date
September 14, 2025
Product description
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
Name
Fujifilm Corporation
Short Name
Fujifilm Corporation
Address
26-30, Nishiazabu 2-chome, Minato-ku, Tokyo 106-8620, JAPAN
Registrant
Name
FUJIFILM HEALTHCARE ASIA PACIFIC PTE LTD
Address
10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Importer
Name
FUJIFILM ASIA PACIFIC PTE LTD FUJIFILM HEALTHCARE ASIA PACIFIC PTE LTD
Address
10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Model information
Model Name(s)
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(s)
DK2623JI -B15- DK2623JI -B20- DK2623JI -N15- DK2623JI -N20-
About this record

Access comprehensive regulatory information for FUJIFILM Diathermic Slitter, Flush Knife, Slim, DK2623JI in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507264 and owned by Fujifilm Corporation. The device was registered on September 15, 2022.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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