Taiwan FDA registration 042ead4f6fae80919dd7881436216e31
"Katia Shurang" ECG recorder
TW: "卡帝亞舒朗" 心電圖紀錄器
Taiwan·Risk Class 2·Dreamtech Co., Ltd.;; Cardiac Insight, Inc.·Registered May 03, 2022 – May 03, 2027ActiveRegistration details
- Analysis ID
- 042ead4f6fae80919dd7881436216e31
- Customs Code
- DHA05603542209
Company information
- Manufacturer
- Dreamtech Co., Ltd.;; Cardiac Insight, Inc.
- Manufacturer Country
- Korea, Republic of;;United States
- Authorized Representative
- SILVER BELL ENTERPRISE INC.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- E Cardiovascular Medicine Science
- Product Type (Level 2)
- E.2340 Telecardiogram
- Import Information
- Input;; Contract manufacturing
Dates and status
- Registration Date
- May 03, 2022
- Expiry Date
- May 03, 2027
About this record
Access comprehensive regulatory information for "Katia Shurang" ECG recorder in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 042ead4f6fae80919dd7881436216e31 and manufactured by Dreamtech Co., Ltd.;; Cardiac Insight, Inc.. The authorized representative in Taiwan is SILVER BELL ENTERPRISE INC..
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