Taiwan FDA registration 8bb7c910c20f78c939fd60ebcc4f7920

"寶billion" Spine manual surgical instrument (unsterilized)

TW: "寶億" 脊椎手動式手術器械(未滅菌)
Taiwan flagTaiwan·Risk Class 1·寶億生技股份有限公司;; Shandong Xinhua Healthcare Industry Co., Limited·Registered Apr 09, 2024 – Apr 09, 2029Active
Registration details
Analysis ID
8bb7c910c20f78c939fd60ebcc4f7920
Customs Code
DHA09600492305
Company information
Manufacturer Country
China;;Taiwan, Province of China
Authorized Representative
BAUI BIOTECH CO., LTD.
Product details
Intended Use
Limited to the classification and grading management measures of medical equipment "Manual orthopedic surgical instruments (N.4540)" first grade identification range.
Product Type (Level 1)
N Orthopedics
Product Type (Level 2)
N.4540 手動式骨科手術器械
Import Information
輸入;; QMS/QSD;; 委託製造
Dates and status
Registration Date
Apr 09, 2024
Expiry Date
Apr 09, 2029
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About this record

Access comprehensive regulatory information for "寶billion" Spine manual surgical instrument (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 8bb7c910c20f78c939fd60ebcc4f7920 and manufactured by 寶億生技股份有限公司;; Shandong Xinhua Healthcare Industry Co., Limited. The authorized representative in Taiwan is BAUI BIOTECH CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 3 companies making similar products including SHANGHAI REACH MEDICAL INSTRUMENT CO., LTD.;; 寶億生技股份有限公司, XINHUA SURGICAL INSTRUMENT CO., LTD.;; 寶億生技股份有限公司, and 3 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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