Taiwan FDA registration a15a665ef55ed112cea82235ac0bb07e

"Opal" Microorganism differentiation and identification device (Non-Sterile)

TW: "澳寶" 微生物鑑別及測定器材 (未滅菌)

Taiwan·Risk Class 1·MD·WHITELEY CORPORATION PTY LTD·Registered Jul 25, 2018 – Jul 25, 2023Expired

Registration details

Analysis ID: a15a665ef55ed112cea82235ac0bb07e
License Form: Ministry of Health Medical Device Import No. 019415
Customs Code: DHA09401941501

Company information

Manufacturer: WHITELEY CORPORATION PTY LTD
Manufacturer Country: Australia
Authorized Representative: JENG CHANG RONG BIOTECH CO., LTD.

Product details

Intended Use: Limited to the first level identification scope of the Measures for the Administration of Medical Devices "Microbial Identification and Measurement Equipment (C.2660)".
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C2660 Microbial identification and assay equipment
Import Information: Imported from abroad

Dates and status

Registration Date: Jul 25, 2018
Expiry Date: Jul 25, 2023

About this record

Access comprehensive regulatory information for "Opal" Microorganism differentiation and identification device (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number a15a665ef55ed112cea82235ac0bb07e and manufactured by WHITELEY CORPORATION PTY LTD. The authorized representative in Taiwan is JENG CHANG RONG BIOTECH CO., LTD..

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