Taiwan FDA registration 58bbae48345246c060e2c4586d9c7693

"Prammica" CAD/CAM optical mold taking system (unsterilized)

TW: "普藍梅卡"CAD/CAM光學取模系統 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·PLANMECA LTD·Registered Oct 01, 2021 – Oct 31, 2024Expired
Registration details
Analysis ID
58bbae48345246c060e2c4586d9c7693
Customs Code
DHA08401442904
Company information
Manufacturer
PLANMECA LTD
Manufacturer Country
Finland
Authorized Representative
EMERGO TAIWAN LIMITED
Product details
Intended Use
Limited to the classification and grading management method of medical equipment, CAD/CAM optical mold taking system (F.3661) first level recognition range.
Product Type (Level 1)
F Dentistry
Product Type (Level 2)
F.3661 CAD/CAM光學取模系統
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Oct 01, 2021
Expiry Date
Oct 31, 2024
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About this record

Access comprehensive regulatory information for "Prammica" CAD/CAM optical mold taking system (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 58bbae48345246c060e2c4586d9c7693 and manufactured by PLANMECA LTD. The authorized representative in Taiwan is EMERGO TAIWAN LIMITED.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including PLANMECA LTD, and 1 recent registrations in the same category. 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.

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