Taiwan FDA registration 29ad2c83702e9022743035c5499de922

“BTL”BTL-08 Holter

TW: “倍達樂”霍特心電圖記錄器
Taiwan flagTaiwan·Risk Class 2·MD·BTL INDUSTRIES LIMITED;;BTL Industries JSC·Registered Mar 24, 2022 – Mar 24, 2027Active
Registration details
Analysis ID
29ad2c83702e9022743035c5499de922
License Form
Ministry of Health Medical Device Import No. 035338
Customs Code
DHA05603533807
Company information
Manufacturer Country
Bulgaria;;United Kingdom
Authorized Representative
K&C MEDICAL 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)
E2340 ECG Scanner;; E2360 electrodes for ECG
Import Information
Imported from abroad
Dates and status
Registration Date
Mar 24, 2022
Expiry Date
Mar 24, 2027
About this record

Access comprehensive regulatory information for “BTL”BTL-08 Holter in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 29ad2c83702e9022743035c5499de922 and manufactured by BTL INDUSTRIES LIMITED;;BTL Industries JSC. The authorized representative in Taiwan is K&C MEDICAL CO., LTD..

This page provides complete technical specifications, regulatory compliance details. 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.

Free DatabasePowered by Pure Global AI89,000+ Devices