Taiwan FDA registration 551217a8b09687da5245a915d6dcc27a
"Heliana" lactate dehydrogenase reagent set (unsterilized)
TW: "賀蓮那" 乳酸脫氫酶試劑組 (未滅菌)
Registration details
- Analysis ID
- 551217a8b09687da5245a915d6dcc27a
- Customs Code
- DHA04401080005
Company information
- Manufacturer
- HELENA LABORATORIES, INC.
- Manufacturer Country
- Japan
- Authorized Representative
- SHANG LI INSTRUMENTS CO., LTD.
Product details
- Intended Use
- Limited to the first level identification range of the lactic acid dehydrogenation test system (A.1440) of the management measures for medical equipment.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1440 Lactate Dehydrogenase Test System
- Import Information
- import
Dates and status
- Registration Date
- Sep 02, 2011
- Expiry Date
- Sep 02, 2016
- Cancellation Date
- Jul 31, 2018
Cancellation information
- Status
- Logged out
- Reason
- 未展延而逾期者
About this record
Access comprehensive regulatory information for "Heliana" lactate dehydrogenase reagent set (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 551217a8b09687da5245a915d6dcc27a and manufactured by HELENA LABORATORIES, INC.. The authorized representative in Taiwan is SHANG LI INSTRUMENTS CO., LTD..
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