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Singapore HSA registration DE0504289

HOYA PENTAX Medical Video Esophagoscope EE17-J10

Singapore flagSingapore·CLASS B·Hoya Corporation·Registered March 30, 2020
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0504289
Registration Date
March 30, 2020
Retention Due Date
March 29, 2026
Product description
The PENTAX Medical Video Esophagoscope EE17-J10 is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach. This endoscope is introduced via the mouth or nose when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
Product Owner
Name
Hoya Corporation
Short Name
Hoya Corporation
Address
6-10-1 Nishi-shinjuku, Shinjuku-ku, Tokyo 160-0023, JAPAN
Registrant
Name
PENTAX MEDICAL SINGAPORE PTE. LTD.
Address
438A ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #08-06, SINGAPORE 119967
Importer
Name
PENTAX MEDICAL SINGAPORE PTE. LTD.
Address
438A ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #08-06, SINGAPORE 119967
Model information
Model Name(s)
PENTAX Medical Video Esophagoscope EE17-J10 Ventilation Cap PVE Soaking Cap Suction Control Valve O-Ring Set Air/Water Feeding Valve Inlet Seal O-Ring Set Bite Block
Model Identifier(s)
EE17-J10 OE-C21 OE-C9 OF-B120 OF-B127 OF-B188 OF-B190 OF-B192 OF-Z5
About this record

Access comprehensive regulatory information for HOYA PENTAX Medical Video Esophagoscope EE17-J10 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504289 and owned by Hoya Corporation. The device was registered on March 30, 2020.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B