Singapore HSA registration DE0016676
Storz Medical DUOLITH® SD1 extracorporeal shockwave therapy system
Singapore·CLASS C·Storz Medical AG·Registered December 23, 2014Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Physical Medicine
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90189030
Registration information
- Registration Number
- DE0016676
- Registration Date
- December 23, 2014
- Change Notification Approval Date
- June 13, 2017
- Retention Due Date
- December 22, 2025
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.
Product Owner
- Name
- Storz Medical AG
- Short Name
- Storz Medical
- Address
- Lohstampfestr. 8, CH-8274, Tagerwilen, SWITZERLAND
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)
- 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) DUOLITH SD1 T-TOP »F-SW ultra« Deep Impact gold applicator (DI15,Ø 15mm) R-SW handpiece (BT) D35-S Applicator set (D35-S, Ø35mm) Handpiece F-SW Sepia transducer 3.5MHz 60mm telemed transducer 9MHz 60mm telemed transducer 9MHz HL9.0/40/128Z-4 Handpiece C-ACTOR Sepia Touch monitor 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 21362 21374 21700 22667 22800 22806 22807 24603 25750 26200 AT BT TT
About this record
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 DE0016676 and owned by Storz Medical AG. The device was registered on December 23, 2014.
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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