Taiwan FDA registration 3a9615ea837b06488292cd03961ef2ae

"Shi Qiu" manual osteologic surgical instrument (sterile/unsterilized)

TW: "史耐輝"手動式骨科手術器械(滅菌/未滅菌)
Taiwan flagTaiwan·Risk Class 1·Made (部分製程) in MALAYSIA;; Smith & Nephew, Inc.·Registered Nov 27, 2013 – Nov 27, 2028Active
Registration details
Analysis ID
3a9615ea837b06488292cd03961ef2ae
Customs Code
DHA09401362702
Company information
Manufacturer Country
United States;;Malaysia
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
Input;; QMS/QSD
Dates and status
Registration Date
Nov 27, 2013
Expiry Date
Nov 27, 2028
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About this record

Access comprehensive regulatory information for "Shi Qiu" manual osteologic surgical instrument (sterile/unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 3a9615ea837b06488292cd03961ef2ae and manufactured by Made (部分製程) in MALAYSIA;; Smith & Nephew, Inc.. The authorized representative in Taiwan is SMITH & NEPHEW ( OVERSEAS ) LIMITED, TAIWAN BRANCH (U.K.).

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including SMITH & NEPHEW ORTHOPAEDICS GMBH, 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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