Taiwan FDA registration 4e0f0bb70e875cab9d5ce0d9a16300bf

"Sundent" Manual surgical instrument for general use (Non-Sterile)

TW: "商登"一般手術用手動式器械 (未滅菌)

Taiwan·Risk Class 1·MD·ROSE METAL ENGINEERING·Registered Jul 28, 2020 – Jul 28, 2025Expired

Registration details

Analysis ID: 4e0f0bb70e875cab9d5ce0d9a16300bf
License Form: Ministry of Health Medical Device Import No. 021793
Customs Code: DHA09402179302

Company information

Manufacturer: ROSE METAL ENGINEERING
Manufacturer Country: Pakistan
Authorized Representative: SUNDENT CORPORATION

Product details

Intended Use: Limited to the first level identification scope of the Measures for the Administration of Medical Devices "Manual Instruments for General Surgery (I.4800)".
Product Type (Level 1): I General and plastic surgical devices
Product Type (Level 2): I4800 General Surgery Manual Instrument
Import Information: Imported from abroad

Dates and status

Registration Date: Jul 28, 2020
Expiry Date: Jul 28, 2025

About this record

Access comprehensive regulatory information for "Sundent" Manual surgical instrument for general use (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 4e0f0bb70e875cab9d5ce0d9a16300bf and manufactured by ROSE METAL ENGINEERING. The authorized representative in Taiwan is SUNDENT CORPORATION.

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