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W&H Amadeo Surgical Unit - HSA Registration DE0507774

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.

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CLASS B
DE0507774
W&H Amadeo Surgical Unit
HSA Registration Number: DE0507774
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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.

Device 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 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