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HSA · registration DE0505694

FUJIFILM Diathermic Slitter, Flush Knife, Slim, DK2620JI

SingaporeGastroenterology & UrologyClass BFujifilm Corporation
Verified
Official record identity
Registration number
DE0505694
Model name
Diathermic slitter, flush knife, slim, DK2620JI; Diathermic slitter, flush knife, slim, DK2620JI; Diathermic slitter, flush knife, slim, DK2620JI; Diathermic slitter, flush knife, slim, DK2620JI; Diathermic slitter, flush knife, slim, DK2620JI; Diathermic slitter, flush knife, slim, DK2620JI; Diathermic slitter, flush knife, slim, DK2620JI; Diathermic slitter, flush knife, slim, DK2620JI; Diathermic slitter, flush knife, slim, DK2620JI
Model identifier
DK2620JI -B15-; DK2620JI -B20-; DK2620JI -B25-; DK2620JI -B30-; DK2620JI -N10-; DK2620JI -N15-; DK2620JI -N20-; DK2620JI -N25-; DK2620JI -N30-
Registration date
April 14, 2021
Source update date
September 09, 2025
Classification
Risk class
Class B
Official value: CLASS B
Published category
Gastroenterology & Urology
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Published parties
Product owner
Fujifilm Corporation
Registrant / registration holder
FUJIFILM HEALTHCARE ASIA PACIFIC PTE. LTD.
Official description

These products are used in combination with an endoscope specified in “Combination of equipment” 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. These products are not intended for use on children and infants.

Additional source fields
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
About this record

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.