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Singapore HSA registration DE0504489

Hoya PENTAX Medical Video Upper GI Scope EG17-J10

Singapore flagSingapore·CLASS B·Hoya Corporation·Registered May 15, 2020
Device classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0504489
Registration Date
May 15, 2020
Retention Due Date
May 14, 2025
Product description
This instrument 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, and duodenum. 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)
Hoya PENTAX Medical Video Upper GI Scope EG17-J10 Suction Valve A/W Feeding Valve Inlet Seal
Model Identifier(s)
EG17-J10 OF-B120 OF-B188 OF-B190
About this record

Access comprehensive regulatory information for Hoya PENTAX Medical Video Upper GI Scope EG17-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 DE0504489 and owned by Hoya Corporation. The device was registered on May 15, 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.

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