Taiwan FDA registration 0dcaa43f248768fe34b80ea4cd57197e
"SHIN TEH" Limb Orthosis (Non-Sterile)
TW: "信得" 肢體裝具 (未滅菌)
Registration details
- Analysis ID
- 0dcaa43f248768fe34b80ea4cd57197e
- License Form
- Ministry of Health Medical Device Import No. 016724
- Customs Code
- DHA09401672402
Company information
- Manufacturer
- DEROYAL INDUSTRIES, INC.
- Manufacturer Country
- United States
- Authorized Representative
- SHIN-TEH INDUSTRIAL CORP.
Product details
- Intended Use
- Limited to the first level recognition range of limb equipment (O.3475) of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- o Equipment for physical medicine
- Product Type (Level 2)
- O3475 Body Equipment
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jun 30, 2016
- Expiry Date
- Jun 30, 2021
About this record
Access comprehensive regulatory information for "SHIN TEH" Limb Orthosis (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 0dcaa43f248768fe34b80ea4cd57197e and manufactured by DEROYAL INDUSTRIES, INC.. The authorized representative in Taiwan is SHIN-TEH INDUSTRIAL CORP..
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI89,000+ Devices