Taiwan FDA registration 2b0e015dfaec39855008ae630545e325
“Nirsit Lite”Optical Topography System
TW: “尼爾斯特萊特”光學式血氧測定儀
Taiwan·Risk Class 2·MD·Obelab Inc.·Registered Sep 11, 2022 – Sep 11, 2027ActiveRegistration details
- Analysis ID
- 2b0e015dfaec39855008ae630545e325
- License Form
- Ministry of Health Medical Device Import No. 035791
- Customs Code
- DHA05603579101
Company information
- Manufacturer
- Obelab Inc.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- TRUSHINE MEDICAL INSTRUMENT CO., LTD.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- E Cardiovascular Medicine Science
- Product Type (Level 2)
- E2700 Oximeter
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Sep 11, 2022
- Expiry Date
- Sep 11, 2027
About this record
Access comprehensive regulatory information for “Nirsit Lite”Optical Topography System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 2b0e015dfaec39855008ae630545e325 and manufactured by Obelab Inc.. The authorized representative in Taiwan is TRUSHINE MEDICAL INSTRUMENT CO., LTD..
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