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Resectoscope System - HSA Registration DE0509311

Access comprehensive regulatory information for Resectoscope System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509311 and owned by Erbe Vision GmbH. The device was registered on May 23, 2024.

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
DE0509311
Resectoscope System
HSA Registration Number: DE0509311
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Product Description

The products are intended for endoscopic diagnosis and treatment during urological and gynecological intervention. Resectoscopy will be used for controlled tissue ablation. Instruments for Resectoscopy connected to proper HF-Cable, are used in combination with suitable HF-Electrodes to perform endoscopic procedures.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0509311
Registration Date
May 23, 2024
Retention Due Date
May 22, 2025
Product Owner
Short Name
Erbe Vision GmbH
Address
Eisenbahnstrasse 102, 78573 Wurmlingen, GERMANY
Registrant
Address
25 INTERNATIONAL BUSINESS PARK, GERMAN CENTRE, #02-61/64, SINGAPORE 609916
Importer
Address
25 INTERNATIONAL BUSINESS PARK, GERMAN CENTRE, #02-55/56, SINGAPORE 609916
Model Information
Model Name(s)
Ball electrode, bipolar, flexible, 5CH, WL 360mm Needle electrode, bipolar, flexible, straight, 5CH; WL 360mm Needle electrode, bipolar, flex., curved, 5CH; WL 360mm Working element monopolar, passive, 26/24CH; for Ø 4mm Working element monopolar, active, 26/24CH; for Ø 4mm Working element bipolar, passive, 26/24CH; for Ø 4mm Working element bipolar, active, 26/24CH; for Ø 4mm Working element, mini, bipolar passive,18.5CH;f.Ø2.9mm 0°&30° Outer sheath, resectoscope, round holes, 26CH; for Ø 4mm Inner sheath, resectoscope, 24CH; for Ø 4mm Outer sheath,resectoscope,mini cont.flow., 18.5CH;for Ø2.9mm Inner sheath,resectoscope,mini 17.5CH; for Ø 2.9mm Loop electrode, resect., mini, angled 17.5CH; for Ø2.9mm 30° Ball electrode, resect., mini, 17.5CH; for Ø 2.9mm 30° Knife electrode, resect., mini angled, 17.5CH;for Ø2.9mm 30° Loop electrode, resect., mini, "straight,17.5CH;f. Ø2.9mm 0° Inner sheath, operating, for 18.5 CH Sheath&Ø2.9mm 30° Sheath for resectoscope, oblique tip, 24 CH Roller electrode, monopolar, serrated, Ø 3mm; for 24CH Roller electrode, monopolar,serrated, Ø 5mm; for 24CH Knife electrode, monopolar,for 24CH Loop electrode, monopolar, straight, for 24CH Loop electrode, monopolar, angled, f. Ø4mm 30°; for 24CH Loop electrode, monopolar, angled, f. Ø4mm 0°; for 24CH Vaporisation electrode, monop. Ø 3mm; for 24CH Conical electrode, monopolar, for 24CH Ball electrode, monopolar, Ø 3mm; for 24CH Ball electrode, monopolar, Ø 5mm; for 24CH Roller electrode, monopolar, plain, Ø 3mm; for 24CH Roller electrode, monopolar, plain, Ø 5mm; for 24CH Roller electrode, bipolar, serrated, Ø 3mm; for 24CH Roller electrode, bipolar, serrated, Ø 5mm; for 24CH Knife electrode, bipolar, for 24CH Loop electrode, bipolar, straight, for 24CH Loop electrode, bipolar, angled, f. Ø4mm 30°; for 24CH Loop electrode, bipolar, angled, f. Ø 4mm 0°; for 24CH Vaporisation electrode,bipolar Ø 3mm; for 24CH Conical electrode, bipolar, for 24CH Ball electrode, bipolar, Ø 3mm; for 24CH Ball electrode, bipolar, Ø 5mm; for 24CH Roller electrode, bipolar, plain, Ø 3mm; for 24CH Roller electrode, bipolar, plain, Ø 5mm; for 24CH
Model Identifier(s)
20862-015 20862-016 20862-017 20862-018 20862-019 20862-020 20862-021 20862-023 20862-024 20862-026 20862-027 20862-028 20862-030 20862-031 20862-032 20862-033 20862-034 20862-039 20862-040 20862-041 20862-042 20862-043 20862-044 20862-045 20862-046 20862-047 20862-048 20862-049 20862-050 20862-051 20862-052 20862-053 20862-054 20862-055 20862-056 20862-057 20862-058 20862-059 20862-060 20862-061 20862-062 20862-063