Taiwan FDA registration fa9537d0510588ebfaaa94f5d7aa09a9
"Kamma" container for storing platelet concentrate (unsterilized)
TW: “神摩”保存血小板濃縮液之容器(未滅菌)
Registration details
- Analysis ID
- fa9537d0510588ebfaaa94f5d7aa09a9
- Customs Code
- DHA04401010309
Company information
- Manufacturer
- THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
- Manufacturer Country
- United States
- Authorized Representative
- BIOWAY CORPORATION
Product details
- Intended Use
- Limited to the first level identification scope of the Measures for the Administration of Medical Devices "Containers for Preserving Platelet Concentrate (B.9575)".
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B.9575 Environmental control chamber for storing platelet concentrate
- Import Information
- import
Dates and status
- Registration Date
- Mar 29, 2011
- Expiry Date
- Mar 29, 2016
- Cancellation Date
- May 21, 2018
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for "Kamma" container for storing platelet concentrate (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number fa9537d0510588ebfaaa94f5d7aa09a9 and manufactured by THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC. The authorized representative in Taiwan is BIOWAY CORPORATION.
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