Taiwan FDA registration 0f67b72b1c7b8b017316b05f15258298

"Deutschland" incubator and cooling board for blood products (unsterilized)

TW: 〝德意志〞血品專用保溫箱及降溫板(未滅菌)

Taiwan·Risk Class 1·FRESENIUS KABI AG·Registered Dec 26, 2005 – Dec 26, 2025Expired

Registration details

Analysis ID: 0f67b72b1c7b8b017316b05f15258298
Customs Code: DHA04400234906

Company information

Manufacturer: FRESENIUS KABI AG
Manufacturer Country: Germany
Authorized Representative: Fresenius Kabi, Taiwan Co., Ltd

Product details

Intended Use: The Compocool II insulated container contains a cooling kit that cools 6 units of whole blood - 400 to 500ml of blood per unit - from 34°C to 22°C±2°C for about 1.5 hours. When transported and stored at room temperature, the temperature can be maintained for 24 hours. Temperature indicator strips on cooling components ensure correct and safe delivery.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.9700 Refrigerator and freezer for blood preservation
Import Information: import

Dates and status

Registration Date: Dec 26, 2005
Expiry Date: Dec 26, 2025

About this record

Access comprehensive regulatory information for "Deutschland" incubator and cooling board for blood products (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 0f67b72b1c7b8b017316b05f15258298 and manufactured by FRESENIUS KABI AG. The authorized representative in Taiwan is Fresenius Kabi, Taiwan Co., Ltd.

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