Taiwan FDA registration 8767ec5bba153c94af9d45d05919d6e5
"BioMaterial" PreOrtho Preformed tooth positioner (NON-STERILE)
TW: "拜歐美"普力歐成形牙齒固定器 (未滅菌)
Taiwan·Risk Class 1·MD·BioMaterials Korae, Inc.·Registered Feb 05, 2020 – Feb 05, 2025ExpiredRegistration details
- Analysis ID
- 8767ec5bba153c94af9d45d05919d6e5
- License Form
- Ministry of Health Medical Device Import No. 021229
- Customs Code
- DHA09402122909
Company information
- Manufacturer
- BioMaterials Korae, Inc.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- HOLISTIC DENTISTRY TAIWAN CO., LTD
Product details
- Intended Use
- Limited to the first-level recognition range of the Measures for the Administration of Medical Devices "Shaped Tooth Retainers (F.5525)".
- Product Type (Level 1)
- F Dental devices
- Product Type (Level 2)
- F5525 Forming Teeth Retainers
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Feb 05, 2020
- Expiry Date
- Feb 05, 2025
About this record
Access comprehensive regulatory information for "BioMaterial" PreOrtho Preformed tooth positioner (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 8767ec5bba153c94af9d45d05919d6e5 and manufactured by BioMaterials Korae, Inc.. The authorized representative in Taiwan is HOLISTIC DENTISTRY TAIWAN CO., LTD.
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