Taiwan FDA registration 622cbdd5ecfd7855229164d92c523b0a

"Hede" platelet oscillator (unsterilized)

TW: “和德”血小板振盪器 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·HOTECH INSTRUMENTS CORP.·Registered Oct 01, 2021 – Oct 31, 2025Expired
Registration details
Analysis ID
622cbdd5ecfd7855229164d92c523b0a
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
HOTECH INSTRUMENTS CORP.
Product details
Intended Use
It is limited to the first level of identification of the "Blood Mixer and Blood Gravimetric Analysis Device (B.9195)" of the Administrative Measures for the Classification and Grading of Medical Devices.
Product Type (Level 1)
B Hematology, pathology, and genetics
Product Type (Level 2)
B.9195 Blood Mixers and Blood Gravimetric Analysis Devices
Import Information
國產;; QMS/QSD
Dates and status
Registration Date
Oct 01, 2021
Expiry Date
Oct 31, 2025
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About this record

Access comprehensive regulatory information for "Hede" platelet oscillator (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 622cbdd5ecfd7855229164d92c523b0a and manufactured by HOTECH INSTRUMENTS CORP.. The authorized representative in Taiwan is HOTECH INSTRUMENTS CORP..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including HOTECH INSTRUMENTS CORP., 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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