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KARL STORZ UNIDRIVE SELECT - HSA Registration DE0508593

Access comprehensive regulatory information for KARL STORZ UNIDRIVE SELECT in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508593 and owned by KARL STORZ SE & Co. KG. The device was registered on October 23, 2023.

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
DE0508593
KARL STORZ UNIDRIVE SELECT
HSA Registration Number: DE0508593
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Product Description

Motor control units are used for electronic regulation and control of motors during surgical operations. Motor control units do not come into contact with the body. The DrillCut-X II-35 shaver handpiece and blades are indicated for minimally invasive interventions in ENT surgery as well as in plastic and neuroendoscopic procedures for controlled excision, morcellation, removal, ablation, and transection of bone/tissue.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0508593
Registration Date
October 23, 2023
Change Notification Approval Date
February 25, 2025
Retention Due Date
October 22, 2025
Product Owner
Short Name
KARL STORZ SE & Co. KG
Address
Dr.-Karl-Storz-StraรŸe 34, 78532 Tuttlingen, GERMANY
Registrant
Address
8 COMMONWEALTH LANE, #03-02/03, SINGAPORE 149555
Importer
Address
8 COMMONWEALTH LANE, GRANDE BUILDING, #03-02, SINGAPORE 149555 8 COMMONWEALTH LANE, #03-02/03, SINGAPORE 149555
Model Information
Model Name(s)
DRILLCUT-X II-35 Shaver Handpiece Shaver Blade, ร˜ 4 mm Shaver Blade, ร˜ 4 mm Shaver Blade, ร˜ 3 mm Shaver Blade, ร˜ 2 mm Shaver Blade, ร˜ 4 mm Shaver Blade, ร˜ 3 mm Shaver Blade, ร˜ 4 mm Shaver Blade, ร˜ 3 mm Shaver Blade, ร˜ 4 mm Shaver Blade, ร˜ 4 mm, 35ยฐ Shaver Blade, ร˜ 4 mm, 65ยฐ Shaver Blade, ร˜ 4 mm, 65ยฐ Shaver Blade, ร˜ 4 mm, 65ยฐ Shaver Blade, ร˜ 3 mm, 65ยฐ Shaver Blade, ร˜ 4 mm, 65ยฐ Shaver Blade, ร˜ 3 mm, 65ยฐ Shaver Blade, ร˜ 4 mm, 65ยฐ Shaver Blade, ร˜ 4 mm, 65ยฐ Shaver Blade, ร˜ 4 mm Shaver Blade, ร˜ 3 mm, 40ยฐ Shaver Blade, ร˜ 4 mm, 40ยฐ Shaver Blade, ร˜ 3 mm, 40ยฐ KARL STORZ UNIDRIVE SELECT KARL STORZ UNIDRIVE SELECT, motor system
Model Identifier(s)
40712035 41201GN 41201KK 41201KKSA 41201KKSB 41201KN 41201KSA 41201LN 41201LSA 41201SN 41202KN 41203GNB 41203GNF 41203KKB 41203KKBA 41203KKF 41203KKFA 41203KNB 41203KNF 41204KKB 41204KKBA 41204KKF 41204KKFA UM600 UM600-1