Taiwan FDA registration 12ea37f18f5b12cae10f9abfc75c8cfa

"WAVE PEP" Dental Hand Instrument (Non-sterile)

TW: "偉平" 牙科手用器械 (未滅菌)

Taiwan·Risk Class 1·MD·INCI DENTAL TIBBI MALZEME SAN. VE TIC. LTD. STI·Registered May 14, 2019 – May 14, 2024Expired

Registration details

Analysis ID: 12ea37f18f5b12cae10f9abfc75c8cfa
License Form: Ministry of Health Medical Device Import No. 020446
Customs Code: DHA09402044602

Company information

Manufacturer: INCI DENTAL TIBBI MALZEME SAN. VE TIC. LTD. STI
Manufacturer Country: Turkey
Authorized Representative: WAVE PEP TRADE CO., LTD.

Product details

Intended Use: Limited to the first level identification scope of the Measures for the Administration of Medical Devices "Dental Hand Instruments (F.4565)".
Product Type (Level 1): F Dental devices
Product Type (Level 2): F4565 Hand instruments for dental use
Import Information: Imported from abroad

Dates and status

Registration Date: May 14, 2019
Expiry Date: May 14, 2024

About this record

Access comprehensive regulatory information for "WAVE PEP" Dental Hand 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 12ea37f18f5b12cae10f9abfc75c8cfa and manufactured by INCI DENTAL TIBBI MALZEME SAN. VE TIC. LTD. STI. The authorized representative in Taiwan is WAVE PEP TRADE CO., LTD..

This page provides complete technical specifications, regulatory compliance details. 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.