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 |
|---|---|---|---|---|---|
| 08806145403582 | TH 1817-05 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403599 | TH 1817-06 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403605 | TH 1817-07 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403612 | TH 1817-08 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403629 | TH 1817-09 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403636 | TH 1817-10 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403643 | TH 1817-11 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403650 | TH 1817-12 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403667 | TH 2018-05 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403674 | TH 2018-06 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403681 | TH 2018-07 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403698 | TH 2018-08 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403704 | TH 2018-11 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403711 | TH 2018-12 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403780 | BS 2018-06 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403797 | BS 2018-07 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403803 | BS 2018-08 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403810 | BS 2018-10 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403827 | BS 2018-12 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403834 | FH 1817-12 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403858 | FH 1716-12 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145403872 | γ-FH 1716-12 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145410009 | γ-SH 12-05 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145410016 | γ-SH 12-06 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145410023 | γ-SH 12-07 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145410030 | γ-SH 12-08 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145410047 | γ-SH 12-10 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145410054 | γ-SH 12-12 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145410061 | γ-SH 13-05 | Absoanchor Microimplant is intended for use as a temporary anchor for orthodontic treatment for use in patients. | 是 | 否 | 否 |
| 08806145410078 | γ-SH 13-06 | 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。