Taiwan FDA registration 5b6c0e8c1f6a5dfe4f6638ef2f69035b

"Alpha Omega" Nonpowered neurosurgical instrument (Non-Sterile)

TW: "艾爾發" 非動力式神經外科用器械 (未滅菌)

Taiwan·Risk Class 1·MD·Alpha Omega Engineering Ltd.·Registered Jul 30, 2019 – Jul 30, 2024Expired

Registration details

Analysis ID: 5b6c0e8c1f6a5dfe4f6638ef2f69035b
License Form: Ministry of Health Medical Device Import No. 020701
Customs Code: DHA09402070102

Company information

Manufacturer: Alpha Omega Engineering Ltd.
Manufacturer Country: Israel
Authorized Representative: KROMAX INTERNATIONAL CORP.

Product details

Intended Use: Limited to the first level identification scope of the Measures for the Administration of Medical Devices "Non-powered Neurosurgical Devices (K.4535)".
Product Type (Level 1): K Devices for neuroscience
Product Type (Level 2): K4535 Non-powered neurosurgical instruments
Import Information: Imported from abroad

Dates and status

Registration Date: Jul 30, 2019
Expiry Date: Jul 30, 2024

About this record

Access comprehensive regulatory information for "Alpha Omega" Nonpowered neurosurgical instrument (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 5b6c0e8c1f6a5dfe4f6638ef2f69035b and manufactured by Alpha Omega Engineering Ltd.. The authorized representative in Taiwan is KROMAX INTERNATIONAL CORP..

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