Taiwan FDA registration c93e18d357a457841b3eff342e8553a3

"Holmedeka" Mitsurin antibiotic bone cement

TW: “好美得卡”特黴素抗生素骨水泥

Taiwan·Risk Class 2·HOWMEDICA INTERNATIONAL S. DE R.L.;; HOWMEDICA OSTEONICS CORP.·Registered Apr 18, 2008 – Apr 18, 2028Active

Registration details

Analysis ID: c93e18d357a457841b3eff342e8553a3
Customs Code: DHA00601900600

Company information

Manufacturer: HOWMEDICA INTERNATIONAL S. DE R.L.;; HOWMEDICA OSTEONICS CORP.
Manufacturer Country: Ireland;;United States
Authorized Representative: STRYKER FAR EAST INC. TAIWAN BRANCH (USA)

Product details

Intended Use: The antibiotic Simplex bone cement containing specific mycin is suitable for second-stage prostheses fixation in the second stage of reorthopedic surgery for all-prosthetic joints.
Product Type (Level 1): N Orthopedics
Import Information: Input;; Contract manufacturing

Dates and status

Registration Date: Apr 18, 2008
Expiry Date: Apr 18, 2028

About this record

Access comprehensive regulatory information for "Holmedeka" Mitsurin antibiotic bone cement in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c93e18d357a457841b3eff342e8553a3 and manufactured by HOWMEDICA INTERNATIONAL S. DE R.L.;; HOWMEDICA OSTEONICS CORP.. The authorized representative in Taiwan is STRYKER FAR EAST INC. TAIWAN BRANCH (USA).

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