Singapore HSA registration DE0507774
W&H Amadeo Surgical Unit
Singapore·CLASS B·W&H Dentalwerk Burmoos GmbH·Registered February 10, 2023Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0507774
- Registration Date
- February 10, 2023
- Retention Due Date
- February 09, 2026
Product description
The drive unit for surgical transmission instruments is indicated for: drilling, milling, cutting, sawing; screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue. Including: ENT surgery, CMF surgery, ribs and thoracic surgery, orthopedics and spine surgery.
Product Owner
- Short Name
- W&H Dentalwerk Burmoos GmbH
- Address
- Ignaz-Glaser-StraBe 53, 5111 Burmoos, AUSTRIA
Registrant
- Address
- 100 PECK SEAH STREET, PS100, #08-14, SINGAPORE 079333
Importer
- Address
- 5 ANG MO KIO INDUSTRIAL PARK 2A, AMK TECH II, #05-21, SINGAPORE 567760
Model information
- Model Name(s)
- S-NW M-UK1023 M-MH40 SET 90000264 SET 90000265
- Model Identifier(s)
- 30264000 30387000 30393000 90000264 90000265
About this record
Access comprehensive regulatory information for W&H Amadeo Surgical Unit in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507774 and owned by W&H Dentalwerk Burmoos GmbH. The device was registered on February 10, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B