Taiwan FDA registration d52ec373cea72d8bbaddb30f6c2fee99
CARDEA SOLO
TW: "卡帝亞舒朗" 心電圖紀錄器
Taiwan·Risk Class 2·MD·Cardiac Insight, Inc.;;Dreamtech Co., Ltd.·Registered May 03, 2022 – May 03, 2027ActiveRegistration details
- Analysis ID
- d52ec373cea72d8bbaddb30f6c2fee99
- License Form
- Ministry of Health Medical Device Import No. 035422
- Customs Code
- DHA05603542209
Company information
- Manufacturer
- Cardiac Insight, Inc.;;Dreamtech Co., Ltd.
- Manufacturer Country
- United States;;Korea, Republic of
- Authorized Representative
- MRS MICRO-WORK COMPANY LIMITED
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- E Cardiovascular Medicine Science
- Product Type (Level 2)
- E2340 ECG Scanner
- Import Information
- Imported from abroad; Contract manufacturing
Dates and status
- Registration Date
- May 03, 2022
- Expiry Date
- May 03, 2027
About this record
Access comprehensive regulatory information for CARDEA SOLO in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number d52ec373cea72d8bbaddb30f6c2fee99 and manufactured by Cardiac Insight, Inc.;;Dreamtech Co., Ltd.. The authorized representative in Taiwan is MRS MICRO-WORK COMPANY LIMITED.
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