MEDCHECK許可證索引
衛部醫器輸字
許可證編號035150
許可證編號035150
輸入器材
醫療器材許可證 ／ 輸入器材
“諾克斯” 睡眠生理訊號記錄系統
“Nox” Sleep Physiological Signals Recording Systems
衛部醫器輸字第035150號
本站收錄狀態核准有效
有效日期2032 / 02 / 07
醫療器材級數第二等級
申請商為 展宙有限公司，收錄 29 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
- 衛部醫器輸字第035150號
- 申請商
- 展宙有限公司 （查看此申請商全部許可證）
- 統一編號
- 28289720
- 申請商地址
- 臺中市西區臺灣大道二段285號20樓(2030室)
- 發證日期
- 2022 / 02 / 07
- 有效日期
- 2032 / 02 / 07
- 限制項目
- 輸 入
- 資料異動日期
- 2026 / 09 / 04
這類器材是什麼 呼吸頻率監視器，AI 輔助整理
呼吸頻率監視器是持續記錄呼吸次數與節律的器材，常見於睡眠檢查、呼吸中止症篩檢和術後或麻醉後監測。在台灣它是醫療器材，需有許可證才能販售。
它跟血氧機差在哪
血氧機看的是血液含氧量，呼吸頻率監視器看的是「呼吸這個動作」的次數和規律。兩者量的是不同東西，睡眠檢查常一起用，因為呼吸中止時血氧會掉、呼吸也會停，單看一項容易漏掉。
誰會用到
- 睡不好、打呼很大聲、白天嗜睡，醫師安排睡眠檢查的人。
- 懷疑有睡眠呼吸中止症，先做居家篩檢的人。
- 手術麻醉後、使用止痛藥期間需要觀察呼吸的人。
- 新生兒或嬰幼兒呼吸監測的特定情況，由醫療團隊評估。
怎麼用才對
這類器材多半要在醫療院所或依指示在家使用，不是買回來自己戴就好。
- 依說明把感應器固定在正確位置，位置跑掉讀數會不準。
- 睡眠檢查通常要記錄一整晚，中途醒來或上廁所不用自己拆掉，先問技術人員。
- 記錄期間避免自行調整參數或關機。
- 數值只是參考，判讀要由醫師搭配其他檢查一起看。
買的時候怎麼確認合法
包裝或機身要有醫療器材許可證字號，格式像「衛部醫器製字第○○○○○○號」，「製」是國內製造、「輸」是進口。本站這個分類目前有 20 張有效許可證，國內製造 7 張、進口 13 張，國外製造廠以 IS、德國、美國各 3 張較多。拿到字號可到本站查是否仍有效。
常見問題
呼吸頻率監視器可以自己買來測睡眠呼吸中止嗎？
不行。這類器材要由醫療人員安排、依指示使用，自行購買在家測，位置和參數沒設定好，結果可能不準，也不能當診斷依據。有打呼、白天嗜睡等情況，應就醫安排檢查。
測出來的數值正常，就代表沒有睡眠呼吸中止嗎？
不一定。單一項呼吸頻率正常，不代表整晚都沒有問題，呼吸中止可能集中在特定睡姿或睡眠階段。判讀要合併血氧、呼吸氣流、腦波等紀錄，由醫師整體評估。
這種器材需要消毒嗎？
看產品設計。本站收錄的型號中，滅菌包裝標示為 0%，代表這類器材通常不是無菌包裝出貨。接觸皮膚的部分依仿單清潔，可重複使用的配件不要與他人共用；單次使用的配件就用完即丟。
戴著監視器睡覺會不會很不舒服？
不一定。多數是貼片、綁帶或墊在床墊下的感應器，習慣後多半能睡著。如果整晚因為器材睡不著，記錄品質會受影響，可以跟技術人員反映，調整固定方式。
本段由 AI 依官方分類輔助整理，僅供認識器材之用，不構成醫療建議。使用前請以醫師指示與產品仿單為準。
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
- 序號有
- 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
- 詳如核定之中文說明書
- 規格
- Nox T3s System with WristOx2
以下空白
製造廠
- 製造商
- Nox Medical ehf.
- 國別
- IS
- 廠址
- Katrinartuni 2, 105 Reykjavik, Iceland
- 製造許可登錄編號
- QSD10300
UDI 型號 共 29 筆
| 基本 DI | 型號 | 產品描述 | 單次使用 | 乳膠 | DEHP |
|---|---|---|---|---|---|
| 00833166001303 | 3150 | Wrist Strap | 否 | 否 | 否 |
| 05707480022076 | M-00-S/50 | ECG Electrodes Wet Gel Stud Connector | 是 | 否 | 否 |
| 05707480022106 | N-00-S/25 | ECG Electrodes Wet Gel Stud Connector | 是 | 否 | 否 |
| 15694311110026 | 951042 | The Nox RIP Belts Disposable are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems. Respiratory effort is important for Sleep Disordered Breathing (SDB) diagnosis and is used to distinguish between central, mixed, and obstructive sleep apnea. If the quality of the measurement is sufficient RIP signal can also be used to derive a secondary flow signal. This is useful if the nasal cannula is dislocated or if the patient is breathing orally. [EN] | 是 | 否 | 否 |
| 15694311110064 | 552110 | The Nox Filter Tube Connector are used to connect luer-lock nasal pressure cannulas/mask pressure tubes to Nox sleep devices [EN] | 是 | 否 | 否 |
| 15694311110170 | 551030 | The Nox RIP Belts Disposable are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems. Respiratory effort is important for Sleep Disordered Breathing (SDB) diagnosis and is used to distinguish between central, mixed, and obstructive sleep apnea. If the quality of the measurement is sufficient RIP signal can also be used to derive a secondary flow signal. This is useful if the nasal cannula is dislocated or if the patient is breathing orally. [EN] | 是 | 否 | 否 |
| 15694311110187 | 551040 | The Nox RIP Belts Disposable are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems. Respiratory effort is important for Sleep Disordered Breathing (SDB) diagnosis and is used to distinguish between central, mixed, and obstructive sleep apnea. If the quality of the measurement is sufficient RIP signal can also be used to derive a secondary flow signal. This is useful if the nasal cannula is dislocated or if the patient is breathing orally. [EN] | 是 | 否 | 否 |
| 15694311110231 | 552010 | Nox Cannula with filter, 40 units | 是 | 否 | 否 |
| 15694311110248 | 552020 | Nox Cannula with Luer-lock, 50 units | 是 | 否 | 否 |
| 15694311110309 | 554023 | The Nox Snap-on Leads are intended to enable recording of EMG/ECG signals during sleep studies. The Snap-on Leads are to be used with industry standard stud electrode pads and connect to a applicable input of a sleep recording device. [EN] | 否 | 否 | 否 |
| 15694311110361 | 554310 | The Nox Snap-on Leads are intended to enable recording of EMG/ECG signals during sleep studies. The Snap-on Leads are to be used with industry standard stud electrode pads and connect to a applicable input of a sleep recording device. [EN] | 否 | 否 | 否 |
| 15694311110378 | 554311 | The Nox Snap-on Leads are intended to enable recording of EMG/ECG signals during sleep studies. The Snap-on Leads are to be used with industry standard stud electrode pads and connect to a applicable input of a sleep recording device. The Nox Snap on Leads with a snap in the color beige are intended for pediatric use. [EN] | 否 | 否 | 否 |
| 15694311110392 | 554313 | The Nox Snap-on Leads are intended to enable recording of EMG/ECG signals during sleep studies. The Snap-on Leads are to be used with industry standard stud electrode pads and connect to a applicable input of a sleep recording device. The Nox Snap on Leads with a snap in the color beige are intended for pediatric use. [EN] | 否 | 否 | 否 |
| 15694311110408 | 554314 | The Nox Snap-on Leads are intended to enable recording of EMG/ECG signals during sleep studies. The Snap-on Leads are to be used with industry standard stud electrode pads and connect to a applicable input of a sleep recording device. [EN] | 否 | 否 | 否 |
| 15694311110415 | 554315 | The Nox Snap-on Leads are intended to enable recording of EMG/ECG signals during sleep studies. The Snap-on Leads are to be used with industry standard stud electrode pads and connect to a applicable input of a sleep recording device. The Nox Snap on Leads with a snap in the color beige are intended for pediatric use. [EN] | 否 | 否 | 否 |
| 15694311110958 | 951012 | The Nox RIP Belts Disposable are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems. Respiratory effort is important for Sleep Disordered Breathing (SDB) diagnosis and is used to distinguish between central, mixed, and obstructive sleep apnea. If the quality of the measurement is sufficient RIP signal can also be used to derive a secondary flow signal. This is useful if the nasal cannula is dislocated or if the patient is breathing orally. [EN] | 是 | 否 | 否 |
| 15694311110965 | 951022 | The Nox RIP Belts Disposable are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems. Respiratory effort is important for Sleep Disordered Breathing (SDB) diagnosis and is used to distinguish between central, mixed, and obstructive sleep apnea. If the quality of the measurement is sufficient RIP signal can also be used to derive a secondary flow signal. This is useful if the nasal cannula is dislocated or if the patient is breathing orally. [EN] | 是 | 否 | 否 |
| 15694311110033 | 951052 | The Nox RIP Belts Disposable are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems. Respiratory effort is important for Sleep Disordered Breathing (SDB) diagnosis and is used to distinguish between central, mixed, and obstructive sleep apnea. If the quality of the measurement is sufficient RIP signal can also be used to derive a secondary flow signal. This is useful if the nasal cannula is dislocated or if the patient is breathing orally. [EN] | 是 | 否 | 否 |
| 15694311110156 | 551010 | The Nox RIP Belts Disposable are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems. Respiratory effort is important for Sleep Disordered Breathing (SDB) diagnosis and is used to distinguish between central, mixed, and obstructive sleep apnea. If the quality of the measurement is sufficient RIP signal can also be used to derive a secondary flow signal. This is useful if the nasal cannula is dislocated or if the patient is breathing orally. [EN] | 是 | 否 | 否 |
| 15694311110163 | 551020 | The Nox RIP Belts Disposable are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems. Respiratory effort is important for Sleep Disordered Breathing (SDB) diagnosis and is used to distinguish between central, mixed, and obstructive sleep apnea. If the quality of the measurement is sufficient RIP signal can also be used to derive a secondary flow signal. This is useful if the nasal cannula is dislocated or if the patient is breathing orally. [EN] | 是 | 否 | 否 |
| 15694311110194 | 551050 | The Nox RIP Belts Disposable are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems. Respiratory effort is important for Sleep Disordered Breathing (SDB) diagnosis and is used to distinguish between central, mixed, and obstructive sleep apnea. If the quality of the measurement is sufficient RIP signal can also be used to derive a secondary flow signal. This is useful if the nasal cannula is dislocated or if the patient is breathing orally. [EN] | 是 | 否 | 否 |
| 15694311110293 | 554022 | The Nox Snap-on Leads are intended to enable recording of EMG/ECG signals during sleep studies. The Snap-on Leads are to be used with industry standard stud electrode pads and connect to a applicable input of a sleep recording device. [EN] | 否 | 否 | 否 |
| 15694311110385 | 554312 | The Nox Snap-on Leads are intended to enable recording of EMG/ECG signals during sleep studies. The Snap-on Leads are to be used with industry standard stud electrode pads and connect to a applicable input of a sleep recording device. [EN] | 否 | 否 | 否 |
| 15694311110422 | 554316 | The Nox Snap-on Leads are intended to enable recording of EMG/ECG signals during sleep studies. The Snap-on Leads are to be used with industry standard stud electrode pads and connect to a applicable input of a sleep recording device. [EN] | 否 | 否 | 否 |
| 15694311110439 | 554317 | The Nox Snap-on Leads are intended to enable recording of EMG/ECG signals during sleep studies. The Snap-on Leads are to be used with industry standard stud electrode pads and connect to a applicable input of a sleep recording device. The Nox Snap on Leads with a snap in the color beige are intended for pediatric use. [EN] | 否 | 否 | 否 |
| 15694311110972 | 951032 | The Nox RIP Belts Disposable are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems. Respiratory effort is important for Sleep Disordered Breathing (SDB) diagnosis and is used to distinguish between central, mixed, and obstructive sleep apnea. If the quality of the measurement is sufficient RIP signal can also be used to derive a secondary flow signal. This is useful if the nasal cannula is dislocated or if the patient is breathing orally. [EN] | 是 | 否 | 否 |
| 15694311111382 | 561212 | The Nox Abdomen Cables are intended to interconnect RIP belts (respiratory effort sensors) and sleep/polysomnography (PSG) systems, to allow measuring of respiratory effort signals. The abdomen cables are designed to enable the usage of the RIP belts with Nox sleep recorders. [EN] | 否 | 否 | 否 |
| 15694311111436 | 561011 | Nox T3s Recorder | 否 | 否 | 否 |
| 15694311111450 | 511012 | Nox T3s System with WristOx2 | 否 | 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。