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Storz Medical DUOLITH® SD1 extracorporeal shockwave therapy system - HSA Registration DE0016814

Access comprehensive regulatory information for Storz Medical DUOLITH® SD1 extracorporeal shockwave therapy system in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0016814 and owned by Storz Medical AG. The device was registered on February 06, 2015.

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 C
DE0016814
Storz Medical DUOLITH® SD1 extracorporeal shockwave therapy system
HSA Registration Number: DE0016814
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Product Description

Storz Medical DUOLITH® SD1 extracorporeal shockwave therapy system is designed for the following indications: plantar fasciitis, tendinopathy/ tendinitis, achillodynia, radia/ulnar humeral epicondylitis, tibial edge syndrome, deep muscle trigger points, superficial muscle trigger points, myofascial trigger points, chronic lower back myofascial pain, skin and soft tissue wounds, skin and soft tissue ulcers (venous, arterial), pressure sores, diabetic foot, burn wounds, CPPS/prostatitis, IPP/Peyronie’s disease, vascular erectile dysfunction, post stroke muscle spasticity.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration Information
Registration Number
DE0016814
Registration Date
February 06, 2015
Retention Due Date
February 05, 2026
Product Owner
Short Name
Storz Medical AG
Address
Lohstampfestrasse 8, CH-8274 Tagerwilen, SWITZERLAND
Registrant
Address
27 TANNERY ROAD, SINGAPORE 347738
Importer
Address
27 TANNERY ROAD, SINGAPORE 347738
Model Information
Model Name(s)
Power cord Applicator set (T10, Ø 10mm) Stand-off pad Ø15mm Stand-off pad Ø30mm F-SW handpiece Applicator R15 incl. Cap (R15, Ø 15mm) Akst. applicator set with cap (A6, Ø 6mm) R-SW handpiece Applicator D40 cpl. V-Actor (V40, Ø40mm) Applicator D25 cpl. V-Actor (V25, Ø25mm) C-15 Applicator Cera max (C15, Ø 15mm) V-Actor handpiece D20 S Applicator standard (D-20S,Ø20mm) D20-T Applicator (D20-T,Ø20 mm) Applicator V10 ball cpl. V-Actor (V10, Ø10mm) ultrasound echoblaster logiscan 128 CEXT-1Z Applicator Set F 15 incl. Cap (F15,Ø 15mm) Deep Impact gold applicator (DI15,Ø 15mm) R-SW handpiece (BT) transducer 9MHz HL9.0/40/128Z D35-S Applicator set (D35-S, Ø35mm) transducer 3.5MHz 60mm telemed transducer 9MHz 60mm telemed Duolith SD1 Tower Duolith SD1 Tower Duolith SD1 T-Top
Model Identifier(s)
13455 13457 15518 16003 16208 17638 17675 18080 18246 19154 19222 19365 21004 21125 21348 21351 21356 21374 21700 21827 22667 22806 22807 AT BT TT