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Olympus OES Elite Ureteroscope - HSA Registration DE0505501

Access comprehensive regulatory information for Olympus OES Elite Ureteroscope in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505501 and owned by Olympus Winter & Ibe GmbH. The device was registered on February 25, 2021.

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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CLASS B
DE0505501
Olympus OES Elite Ureteroscope
HSA Registration Number: DE0505501
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Product Description

The Olympus ureteroscopes can be utilized for endoscopic observation and therapy in the ureters, urethra, and urinary bladder. Semi-rigid optical instrument for the visualization of the following diagnostic and therapeutic procedures: - Transurethral inspection of the ureters and renal pelvis for diagnosis - Transurethral insertion of catheters, guide wires, cannulas, forceps, baskets, lithotripsy probes and laser fibers into the ureter - Transurethral treatment and removal of tissue, catheters, guide wires, debris and stones from urethra, urinary bladder and ureters - Transurethral treatment and removal of tissue and stones from the ureters and renal pelvis. The products are not intended for treatment of infants. For children (>2 years) and adults, refer to the particular constitution and anatomy of the patient.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0505501
Registration Date
February 25, 2021
Retention Due Date
February 24, 2026
Product Owner
Short Name
Olympus Winter & Ibe GmbH
Address
Kuehnstr. 61, 22045 Hamburg, GERMANY
Registrant
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #03-07/12, SINGAPORE 119968
Importer
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #03-07/12, SINGAPORE 119968
Model Information
Model Name(s)
Ureteroscope, 6.7/8.4 Fr. x 430 mm, 5ยฐ, angled ocular, 4.2 Fr. Channel Ureteroscope, 6.7/8.4 Fr. x 330 mm, 5ยฐ, straight ocular, 4.2 Fr. Channel Ureteroscope, 6.7/8.4 Fr. x 430 mm, 5ยฐ, straight ocular, 4.2 Fr. Channel Ureteroscope, 7.3/10.4 Fr. x 430 mm, 5ยฐ, angled ocular, 6.4 Fr. Channel Ureteroscope, 6.9/8.4 Fr. x 430 mm, 5ยฐ, angled ocular, 3.7 Fr. and 2.6 Fr. Channel Ureteroscope, 6.9/8.4 Fr. x 330 mm, 5ยฐ, straight ocular, 3.7 Fr. and 2.6 Fr. Channel Ureteroscope, 6.9/8.4 Fr. x 430 mm, 5ยฐ, straight ocular, 3.7 Fr. and 2.6 Fr. Channel Attachment, for OES ELITE ureteroscopes Ureteroscope, set, WA2UR11A with WA00387A Ureteroscope, set, WA2UR12A with WA00387A Ureteroscope, set, WA2UR13A with WA00387A Ureteroscope, set, WA2UR14A with WA00387A Ureteroscope, set, WA2UR21A with WA00387A Ureteroscope, set, WA2UR22A with WA00387A Ureteroscope, set, WA2UR23A with WA00387A Ureteroscope, set, WA2UR21A with A0387 and 2x WA2URADP Ureteroscope, set, WA2UR11A with A0387 and WA2URADP Ureteroscope, set, WA2UR12A with A0387 and WA2URADP Ureteroscope, set, WA2UR13A with A0387 and WA2URADP Ureteroscope, set, WA2UR14A with A0387 and 2x WA2URADP
Model Identifier(s)
WA2UR11A WA2UR12A WA2UR13A WA2UR14A WA2UR21A WA2UR22A WA2UR23A WA2URADP WA2URS01 WA2URS02 WA2URS03 WA2URS04 WA2URS05 WA2URS06 WA2URS07 WA2URS10 WA2URS11 WA2URS12 WA2URS13 WA2URS14