Taiwan FDA registration 7d398ace9739a2b05080506c47e13406
"Acro" digital mammogram system
TW: “安科” 數位乳房X光攝影系統
Taiwan·Risk Class 2·Shenzhen Anke High-tech Co., Ltd.·Registered Oct 05, 2021 – Oct 05, 2026ActiveRegistration details
- Analysis ID
- 7d398ace9739a2b05080506c47e13406
- Customs Code
- DHAS9200126302
Company information
- Manufacturer
- Shenzhen Anke High-tech Co., Ltd.
- Manufacturer Country
- China
- Authorized Representative
- DERMACARE BIOMED INC.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- P Radiology Science
- Product Type (Level 2)
- P.1710 乳房X光系統
- Import Information
- Input;; Consent must be attached to the import (with the consent of the Atomic Energy Commission must be obtained for each import); Chinese goods
Dates and status
- Registration Date
- Oct 05, 2021
- Expiry Date
- Oct 05, 2026
About this record
Access comprehensive regulatory information for "Acro" digital mammogram system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7d398ace9739a2b05080506c47e13406 and manufactured by Shenzhen Anke High-tech Co., Ltd.. The authorized representative in Taiwan is DERMACARE BIOMED INC..
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