Taiwan FDA registration d47bb3c084c9469d51736a349454e123
Spellman diagnostic X-ray tube sleeve assembly (unsterilized)
TW: “斯派曼”診斷用X光球管套組件 (未滅菌)
Registration details
- Analysis ID
- d47bb3c084c9469d51736a349454e123
- Customs Code
- DHAS9401394001
Company information
- Manufacturer
- SPELLMAN HIGH VOLTAGE ELECTRONICS CORPORATION
- Manufacturer Country
- United States
- Authorized Representative
- Taiwan Tengxie Biotechnology Co., Ltd
Product details
- Intended Use
- Limited to the first-level identification range of the Measures for the Administration of Medical Devices "X-ray Tube Sleeve Components for Diagnosis (P.1760)".
- Product Type (Level 1)
- P Radiology Science
- Product Type (Level 2)
- P.1760 診斷用X光球管套組件
- Import Information
- Consent must be attached to the import (with the consent of the Atomic Energy Commission must be obtained for each import); input
Dates and status
- Registration Date
- Mar 10, 2014
- Expiry Date
- Mar 10, 2019
- Cancellation Date
- Jun 16, 2022
Cancellation information
- Status
- Logged out
- Reason
- 自行鍵入
About this record
Access comprehensive regulatory information for Spellman diagnostic X-ray tube sleeve assembly (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number d47bb3c084c9469d51736a349454e123 and manufactured by SPELLMAN HIGH VOLTAGE ELECTRONICS CORPORATION. The authorized representative in Taiwan is Taiwan Tengxie Biotechnology Co., Ltd.
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