Taiwan FDA registration 3c7c4bbf7496f5965de653d6caa278e9

"Dibo" Double Test Kit - Streptococcus pneumoniae/Legionella pneumophila urine antigen test (unsterilized)

TW: "帝博" 雙測試套組-肺炎鏈球菌/嗜肺軍團菌尿抗原檢測 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·STATENS SERUM INSTITUT (SSI)·Registered Apr 26, 2016 – Apr 26, 2021Cancelled
Registration details
Analysis ID
3c7c4bbf7496f5965de653d6caa278e9
Customs Code
DHA09401645205
Company information
Manufacturer Country
Denmark
Authorized Representative
DYBO ENTERPRISE COMPANY LIMITED
Product details
Intended Use
Limited to the management method of medical equipment, Haemophilus serological reagent (C.3300) and streptococcus serum reagent (C.3740) The first level identification range is limited.
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.3300 嗜血桿菌屬血清試劑;; C.3740 鏈球菌屬血清試劑
Import Information
import
Dates and status
Registration Date
Apr 26, 2016
Expiry Date
Apr 26, 2021
Cancellation Date
Aug 15, 2023
Cancellation information
Status
Logged out
Reason
許可證已逾有效期
About this record

Access comprehensive regulatory information for "Dibo" Double Test Kit - Streptococcus pneumoniae/Legionella pneumophila urine antigen test (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 3c7c4bbf7496f5965de653d6caa278e9 and manufactured by STATENS SERUM INSTITUT (SSI). The authorized representative in Taiwan is DYBO ENTERPRISE COMPANY LIMITED.

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