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Singapore HSA registration DE0019251

V2U O-Wave I Shockwave Therapy System

Singapore flagSingapore·CLASS B·V 2 U HEALTHCARE PTE. LTD·Registered May 17, 2017
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0019251
Registration Date
May 17, 2017
Change Notification Approval Date
July 07, 2020
Retention Due Date
May 16, 2025
Product description
The O-wave I used in the area of adjuvant therapy of chronic and acute join pain and be used by medical staff. Acute: Radial and Ulnar epicondylitis, Tendinitis of Shoulder/Shoulder Problems, Calcific Tendinitis of the Shoulder, Status post muscular injury, Patellar Tendinitis, Patellar Tendinopathy, Achillodynia, Planar Fasciatis, Heel Spur, Myofascial trigger point Neck and Back, Trochantric Bursitis, Periostitis Shin Splint Condition. Chronic: Radial and Ulnar epicondylitis, Tendinitis of Shoulder/Shoulder Problems, Calcific Tendinitis of the Shoulder, Status post muscular injury, Patellar Tendinitis, Patellar Tendinopathy, Achillodynia, Planar Fasciatis, Myofascial trigger point Neck and Back, Trochantric Bursitis, Periostitis Shin Splint Condition
Product Owner
Name
V 2 U HEALTHCARE PTE. LTD
Short Name
V 2 U HEALTHCARE PTE. LTD
Address
22 SIN MING LANE, MIDVIEW CITY, #07-88, SINGAPORE 573969
Registrant
Name
V 2 U HEALTHCARE PTE. LTD.
Address
22 SIN MING LANE, MIDVIEW CITY, #07-88, SINGAPORE 573969
Importer
Name
V 2 U HEALTHCARE PTE. LTD.
Address
22 SIN MING LANE, MIDVIEW CITY, #07-88, SINGAPORE 573969
Model information
Model Name(s)
O-wave I O-wave I
Model Identifier(s)
V2U-RPW-PT1 V2U-RPW-PT2
About this record

Access comprehensive regulatory information for V2U O-Wave I Shockwave Therapy 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 DE0019251 and owned by V 2 U HEALTHCARE PTE. LTD. The device was registered on May 17, 2017.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B