Taiwan FDA registration 67deff629258579a2d7dc1cd80c3a455
Roche Vantana slide scanner
TW: 羅氏凡塔那玻片掃描器
Taiwan·Risk Class 2·ROCHE DIAGNOSTICS GMBH;; Carl Zeiss CMP GmbH·Registered Apr 26, 2024 – Apr 26, 2029ActiveRegistration details
- Analysis ID
- 67deff629258579a2d7dc1cd80c3a455
- Customs Code
- DHA05603707600
Company information
- Manufacturer
- ROCHE DIAGNOSTICS GMBH;; Carl Zeiss CMP GmbH
- Manufacturer Country
- Germany
- Authorized Representative
- ROCHE DIAGNOSTICS LTD.
Product details
- Intended Use
- This product is a computerized imaging device that has the functions of scanning stained tissue samples on slides, digitizing, compressing, storing, retrieving, and viewing digitized images of tissue section samples on slides. When used with uPath, this product can be used to automatically scan stained tissue samples on slides and provide automated digital slide creation, management, and viewing to assist professionals in performing in vitro examination of human tissue samples.
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B.3700 Pathology Slide Imaging System
- Import Information
- QMS/QSD;; 輸入;; 委託製造
Dates and status
- Registration Date
- Apr 26, 2024
- Expiry Date
- Apr 26, 2029
About this record
Access comprehensive regulatory information for Roche Vantana slide scanner in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 67deff629258579a2d7dc1cd80c3a455 and manufactured by ROCHE DIAGNOSTICS GMBH;; Carl Zeiss CMP GmbH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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