Taiwan FDA registration 30aceb3d906dffe8188ca23cbbf7bfdd

"Hiroka" laryngeal mask (sterilized)

TW: "廣鎬" 喉罩 (滅菌)

Taiwan·Risk Class 1·OMNIMATE ENTERPRISE CO., LTD.·Registered Sep 06, 2016 – Sep 06, 2026Active

Registration details

Analysis ID: 30aceb3d906dffe8188ca23cbbf7bfdd

Company information

Manufacturer: OMNIMATE ENTERPRISE CO., LTD.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: OMNIMATE ENTERPRISE CO., LTD.

Product details

Intended Use: Limited to the classification and grading management method of medical equipment, oropharyngeal airway canal (D.5110) first grade identification range.
Product Type (Level 1): D Anesthesiology
Product Type (Level 2): D.5110 Oropharyngeal airway tubes
Import Information: QMS/QSD;; 國產

Dates and status

Registration Date: Sep 06, 2016
Expiry Date: Sep 06, 2026

About this record

Access comprehensive regulatory information for "Hiroka" laryngeal mask (sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 30aceb3d906dffe8188ca23cbbf7bfdd and manufactured by OMNIMATE ENTERPRISE CO., LTD.. The authorized representative in Taiwan is OMNIMATE ENTERPRISE CO., LTD..

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