MEDCHECK許可證索引
衛署醫器輸字
許可證編號010156
許可證編號010156
輸入器材
醫療器材許可證 ／ 輸入器材
"史賽克" 基本骨板組
"STRYKER" BASIC FRAGMENT SET
衛署醫器輸字第010156號
本站收錄狀態核准有效
有效日期2027 / 12 / 18
醫療器材級數第二等級
申請商為 美商史賽克（遠東）有限公司台灣分公司，收錄 327 個 UDI 型號。 以下整理許可證、規格與製造廠資料，供核對產品身分使用。
許可證資料 依公開資料欄位整理
- 許可證字號
- 衛署醫器輸字第010156號
- 申請商
- 美商史賽克（遠東）有限公司台灣分公司 （查看此申請商全部許可證）
- 統一編號
- 22765253
- 申請商地址
- 臺北市中正區羅斯福路2段100號5樓之1
- 發證日期
- 2002 / 12 / 18
- 有效日期
- 2027 / 12 / 18
- 限制項目
- 輸 入
- 資料異動日期
- 2022 / 10 / 06
UDI 標示 依 UDI 資料彙整
- 單次使用是
- 滅菌包裝否
- 天然橡膠（乳膠）不含
- DEHP不含
- 批號有
- 序號無
- 製造日期有
- 有效期限無
- 健保特材未填
這張許可證底下有多個型號時，只要其中一款有標示，就顯示為「是」或「有」。
效能與規格
- 規格
- 詳如中文仿單核定本。詳如中文仿單核定本。註銷規格：詳如中文仿單核定本，原93.8.4核定之標籤、仿單核定本予以回收作廢。註銷規格：432126。註銷規格：詳如核定之中文說明書，以下空白。註銷規格：340655、601038及601100，以下空白。
製造廠
- 製造商
- Stryker GmbH
- 國別
- 瑞士
- 廠址
- BOHNACKERWEG 1 CH-2545 SELZACH SWITZERLAND
- 製造許可登錄編號
- QSD4292
UDI 型號 共 327 筆
| 基本 DI | 型號 | 產品描述 | 單次使用 | 乳膠 | DEHP |
|---|---|---|---|---|---|
| 04546540069665 | 432002 | Waisted Compression Plate Narrow SPS Large Fragment 2 Holes / L38mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069672 | 432003 | Waisted Compression Plate Narrow SPS Large Fragment 3 Holes / L56mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069689 | 432004 | Waisted Compression Plate Narrow SPS Large Fragment 4 Holes / L74mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069696 | 432005 | Waisted Compression Plate Narrow SPS Large Fragment 5 Holes / L92mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069702 | 432006 | Waisted Compression Plate Narrow SPS Large Fragment 6 Holes / L110mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069719 | 432007 | Waisted Compression Plate Narrow SPS Large Fragment 7 Holes / L128mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069726 | 432008 | Waisted Compression Plate Narrow SPS Large Fragment 8 Holes / L146mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069733 | 432009 | Waisted Compression Plate Narrow SPS Large Fragment 9 Holes / L164mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069740 | 432010 | Waisted Compression Plate Narrow SPS Large Fragment 10 Holes / L182mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069757 | 432011 | Waisted Compression Plate Narrow SPS Large Fragment 11 Holes / L200mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069764 | 432012 | Waisted Compression Plate Narrow SPS Large Fragment 12 Holes / L218mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069771 | 432013 | Waisted Compression Plate Narrow SPS Large Fragment 13 Holes / L236mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069788 | 432014 | Waisted Compression Plate Narrow SPS Large Fragment 14 Holes / L254mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069795 | 432015 | Waisted Compression Plate Narrow SPS Large Fragment 15 Holes / L272mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069801 | 432016 | Waisted Compression Plate Narrow SPS Large Fragment 16 Holes / L290mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069825 | 432018 | Waisted Compression Plate Narrow SPS Large Fragment 18 Holes / L326mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069917 | 432054 | Standard Compression Plate Narrow SPS Large Fragment 4 Holes / L74mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069924 | 432055 | Standard Compression Plate Narrow SPS Large Fragment 5 Holes / L92mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069931 | 432056 | Standard Compression Plate Narrow SPS Large Fragment 6 Holes / L110mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069948 | 432057 | Standard Compression Plate Narrow SPS Large Fragment 7 Holes / L128mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069955 | 432058 | Standard Compression Plate Narrow SPS Large Fragment 8 Holes / L146mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069962 | 432059 | Standard Compression Plate Narrow SPS Large Fragment 9 Holes / L164mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069979 | 432060 | Standard Compression Plate Narrow SPS Large Fragment 10 Holes / L182mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069986 | 432061 | Standard Compression Plate Narrow SPS Large Fragment 11 Holes / L200mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540069993 | 432062 | Standard Compression Plate Narrow SPS Large Fragment 12 Holes / L218mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540070005 | 432063 | Standard Compression Plate Narrow SPS Large Fragment 13 Holes / L236mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540070012 | 432064 | Standard Compression Plate Narrow SPS Large Fragment 14 Holes / L254mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540070029 | 432065 | Standard Compression Plate Narrow SPS Large Fragment 15 Holes / L272mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540070142 | 432106 | Waisted Compression Plate Broad SPS Large Fragment 6 Holes / L112mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
| 04546540070159 | 432107 | Waisted Compression Plate Broad SPS Large Fragment 7 Holes / L130mm for Screws Dia.4.5/6.5mm | 是 | 否 | 否 |
找的不是這個型號？
可改用包裝上的完整型號或許可證字號查詢。