MEDCHECK許可證索引
衛署醫器輸字
許可證編號010948
許可證編號010948
輸入器材
醫療器材許可證 ／ 輸入器材
"登特斯"骨內固定植體系列
"DENTOS" INTRAOSSEOUS FIXATION SCREWS
衛署醫器輸字第010948號
本站收錄狀態核准有效
有效日期2029 / 12 / 07
醫療器材級數第三等級
申請商為 新雅貿易有限公司，收錄 748 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010948號
- 申請商
- 新雅貿易有限公司 （查看此申請商全部許可證）
- 統一編號
- 04629398
- 申請商地址
- 臺北市中正區南昌路1段147巷2弄2號1樓
- 發證日期
- 2004 / 12 / 07
- 有效日期
- 2029 / 12 / 07
- 限制項目
- 輸 入
- 資料異動日期
- 2024 / 07 / 19
UDI 標示 依 UDI 資料彙整
- 單次使用是
- 滅菌包裝未填
- 天然橡膠（乳膠）不含
- DEHP不含
- 批號有
- 序號無
- 製造日期有
- 有效期限有
- 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
- 效能
- 詳如中文仿單核定本
- 規格
- 詳如中文仿單核定本。增加規格，詳如中文仿單核定本(原93年12月16日核准之仿單、標籤核定本予以回收作廢)。註銷規格(共1項):SH1-12，以下空白。
製造廠
- 製造商
- DENTOS INC.
- 國別
- 南韓
- 廠址
- 41, Seongseo-ro 68-gil, Dalseo-Gu, Daegu, Korea
- 製造許可登錄編號
- QSD5244
UDI 型號 共 748 筆
| 基本 DI | 型號 | 產品描述 | 單次使用 | 乳膠 | DEHP |
|---|---|---|---|---|---|
| 08806145400178 | SH 14-10 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400185 | SH 14-12 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400192 | SH 1211-05 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400208 | SH 1211-06 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400215 | SH 1211-07 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400222 | SH 1211-08 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400239 | SH 1211-10 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400246 | SH 1211-12 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400253 | SH 1312-05 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400260 | SH 1312-06 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400277 | SH 1312-07 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400284 | SH 1312-08 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400291 | SH 1312-10 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400307 | SH 1312-12 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400314 | SH 1413-05 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400321 | SH 1413-06 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400338 | SH 1413-07 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400345 | SH 1413-08 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400352 | SH 1413-10 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400369 | SH 1413-12 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400376 | SH 1514-05 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400383 | SH 1514-06 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400390 | SH 1514-07 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400406 | SH 1514-08 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400413 | SH 1514-10 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400420 | SH 1514-12 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400437 | SH 1615-05 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400444 | SH 1615-06 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400451 | SH 1615-07 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145400468 | SH 1615-08 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 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。