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"Dibo" Double Test Kit - Streptococcus pneumoniae/Legionella pneumophila urine antigen test (unsterilized) - Taiwan Registration 3c7c4bbf7496f5965de653d6caa278e9

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.

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3c7c4bbf7496f5965de653d6caa278e9
Registration Details
Taiwan FDA Registration: 3c7c4bbf7496f5965de653d6caa278e9
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Device Details

"Dibo" Double Test Kit - Streptococcus pneumoniae/Legionella pneumophila urine antigen test (unsterilized)
TW: "ๅธๅš" ้›™ๆธฌ่ฉฆๅฅ—็ต„-่‚บ็‚Ž้ˆ็ƒ่Œ/ๅ—œ่‚บ่ปๅœ˜่ŒๅฐฟๆŠ—ๅŽŸๆชขๆธฌ (ๆœชๆป…่Œ)
Risk Class 1
Cancelled

Registration Details

3c7c4bbf7496f5965de653d6caa278e9

DHA09401645205

Company Information

Denmark

Product Details

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.

C Immunology and microbiology

C.3300 ๅ—œ่ก€ๆกฟ่Œๅฑฌ่ก€ๆธ…่ฉฆๅŠ‘;; C.3740 ้ˆ็ƒ่Œๅฑฌ่ก€ๆธ…่ฉฆๅŠ‘

import

Dates and Status

Apr 26, 2016

Apr 26, 2021

Aug 15, 2023

Cancellation Information

Logged out

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