Taiwan FDA registration 0dcf46152bc1c147502785457cd13c1f

"Zentek" digital monitoring system

TW: “擅特克”數位監測系統
Taiwan flagTaiwan·Risk Class 2·SENTEC AG·Registered Feb 09, 2022 – Feb 09, 2027Active
Registration details
Analysis ID
0dcf46152bc1c147502785457cd13c1f
Customs Code
DHA05603530100
Company information
Manufacturer
SENTEC AG
Manufacturer Country
Switzerland
Authorized Representative
BROJAW INC.
Product details
Intended Use
Details are as detailed as approved Chinese instructions
Product Type (Level 1)
D Anesthesiology; E Cardiovascular Medicine Science
Product Type (Level 2)
E.2710 Auricular blood oximetry and measuring instrument;; D.2500 Oxygen monitor on the surface of the skin (non-invasive); D.2480 Carbon dioxide monitor on skin surface (non-invasive)
Import Information
import
Dates and status
Registration Date
Feb 09, 2022
Expiry Date
Feb 09, 2027
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About this record

Access comprehensive regulatory information for "Zentek" digital monitoring system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 0dcf46152bc1c147502785457cd13c1f and manufactured by SENTEC AG. The authorized representative in Taiwan is BROJAW INC..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including SENTEC AG, and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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