已注册医疗器械名录（2026年4月，CSV）
这份数据说明了什么
由 Health Sciences Authority 发布。 共 20,860 条记录。 字段包括 Device Name, Description, Medical Speciality Area, Medical Device Class（共 13 列）。 时间范围：2004-05-01 至 2026-04-30。 最近更新：2026-06-08。
简介
本数据集由卫生科学局发布，为截至2026年4月的新加坡医疗器械注册簿（SMDR）CSV快照，含器械名称、用途、专科、风险等级、注册信息、所有人与型号等（追溯至2004年）。临床与采购人员可核对上市器械；亦可经 https://www.hsa.gov.sg/e-services/infosearch 查询。
官方简介
新加坡医疗器械注册簿（SMDR）由卫生科学局维护，为新加坡所有已注册医疗器械的官方库。登记载明器械名称、预期用途、医学专科、风险等级（B/C/D类）、注册日期与编号、产品所有人与注册人及型号等。 SMDR亦可通过HSA电子服务门户 https://www.hsa.gov.sg/e-services/infosearch 中“Singapore Medical Device Register (SMDR)”公开查询。
- 最近更新
- 覆盖范围
- 2004-05-01 – 2026-04-30
- 行数
- 20,860
- 列数
- 13
数据
| Device Name | Description | Medical Speciality Area | Medical Device Class | Device Registration Number | Registration Date | Change Notification Approval Date | Product Owner Name | Product Owner Address | Registrant Name | Registrant Address | Model Name |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Eye Instruments | A collection of devices and materials intended to be used in a ophthalmic (eye)... | General Hospital | CLASS B | MDPR260520Z0003 | 20/05/2026 01:04 | PPM Medical Pte Ltd | 2 BUKIT BATOK STREET 23, #08-05, BUKIT BATOK CONNECTION, Singapore 659554 | PPM MEDICAL PTE. LTD. | 2 BUKIT BATOK STREET 23, #08-05, BUKIT BATOK CONNECTION, Singapore 659554 | Stallard scissors; Westcott scissors dolphin nose; Westcott Scissors Dolphin Nos... | |
| Philips Smart Fit Coils | Philips Magnetic Resonance (MR) Receive-only (Rx) coils are intended to be used... | General Hospital | CLASS B | MDPR260520X0001 | 20/05/2026 01:03 | Philips Healthcare (Suzhou) Co., Ltd. | No. 258, ZhongYuan Road, Suzhou Industrial Park, 215024 Suzhou, Jiangsu Province... | PHILIPS ELECTRONICS SINGAPORE PTE LTD | 622 LORONG 1 TOA PAYOH, Singapore 319763 | Smart Fit TorsoCardiac 1.5T ; Smart Fit Shoulder 1.5T; Smart Fit Knee 3.0T | |
| ConMed TruFire Suture Passer Needle | The TruFire™ Suture Passer system is indicated to aid passing sutures through ti... | Orthopaedics | CLASS B | MDPR260520Y0002 | 20/05/2026 01:03 | CONMED CORPORATION | 525 FRENCH ROAD, UTICA, NEW YORK 13502, UNITED STATES OF AMERICA, United States | CONMED SINGAPORE PTE. LTD. | 10 JALAN KILANG, #03-01, BT MERAH ENTERPRISE CENTRE, Singapore 159410 | TruFire® Suture Passer Needle | |
| Foosin Medical Supplies WEGO POLYESTER Non-absorbable Surgical Sutures | WEGO POLYESTER sutures are indicated for use in general soft tissue approximatio... | General & Plastic Surgery | CLASS D | MDPR260519K0006 | 19/05/2026 18:56 | Foosin Medical Supplies Inc., Ltd. | No. 8-1, Weigao West Road, Chucun Town,, Torch Hi-Tech Science Park, Weihai, Sha... | TOPMED PTE. LTD. | 10 BUKIT BATOK CRESCENT, #10-02, THE SPIRE, Singapore 658079 | WEGO-POLYESTER; WEGO-POLYESTER; WEGO-POLYESTER; WEGO-POLYESTER; WEGO-POLYESTER;... | |
| mesoestetic mesohyal NCTC 109 | mesohyal NCTC 109 is a dermal filler of hyaluronic acid for rejuvenation and rev... | General & Plastic Surgery | CLASS D | MDPR260519J0005 | 19/05/2026 18:55 | mesoestetic Pharma Group S.L | Calle Tecnologia, 25, 08840 Viladecans (Barcelona), Spain, Spain | NEOASIA (S) PTE LTD | 6 TAGORE DRIVE, #04-06/07, TAGORE INDUSTRIAL BUILDING, Singapore 787623 | mesohyal NCTC 109; mesohyal NCTC 109 | |
| Shanghai United Imaging Health uDR Digital Medical X-ray Imaging System | The system is intended to acquire X-ray images of the human body by a qualified... | General Hospital | CLASS C | MDPR260519I0004 | 19/05/2026 16:27 | Shanghai United Imaging Health Co. Ltd. | No.2258 Chengbei Rd., Jiading District 201807, Shanghai, China | UNITED IMAGING HEALTHCARE PTE. LTD. | 38 BEACH ROAD, #29-11, SOUTH BEACH TOWER, Singapore 189767 | Digital Medical X-ray Imaging System | |
| Brainlab Automatic Registration | Automatic Registration is a software device for image guided surgery intended to... | General Hospital | CLASS C | MDPR260519F0001 | 19/05/2026 01:03 | Brainlab SE | Olof-Palme-Straße 9 81829 Munich, Germany | BRAINLAB LIMITED (Singapore Branch) | 135 CECIL STREET, #10-01, PHILIPPINE AIRLINES BUILDING, Singapore 069536 | Automatic Registration 2.7 | |
| Sterylab Bone Tissue Biopsy Devices | Sterylab Bone Tissue Biopsy Devices are surgical invasive devices for temporary... | General & Plastic Surgery | CLASS B | MDPR260519H0003 | 19/05/2026 01:03 | STERYLAB S.r.l. | Via Magenta, 77/6 - IT 20017 RHO (MI), Italy | FAR EASTERN MEDICAL | 10 UBI CRESCENT, #05-18, UBI TECHPARK, Singapore 408564 | BEN; BEN; BEN; BEN; BEN; BEN; BEN; BEN; BEST-LISAS; BEST-LISAS; BEST-LISAS; BEST... | |
| Positive Airway Pressure Units YH-680B | Indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients w... | General Hospital | CLASS B | MDPR260519G0002 | 19/05/2026 01:03 | Suzhou Yuyue Medical Technology Co.,Ltd. | No.9 Jinfeng Road, Suzhou Science&Technology Town, 215163 Suzhou, Jiangsu, PEOPL... | MEDICO PTE. LTD. | 27 NEW INDUSTRIAL ROAD, #03-03, NOVELTY TECHPOINT, Singapore 536212 | Air filter; Air tube; Bag; heated tubing; power adapter and cable; User manual;... | |
| Shanghai United Imaging Intelligence MRI Image Analysis Software | MRI Image Analysis software is a software solution intended to be used for viewi... | Radiology / Imaging | CLASS B | MDPR260518E0001 | 18/05/2026 15:31 | Shanghai United Imaging Intelligence Co., Ltd. | No. 701 Yunjin Road, Xuhui District, Shanghai, 200232,, People’s Republic of Chi... | UNITED IMAGING HEALTHCARE PTE. LTD. | 38 BEACH ROAD, #29-11, SOUTH BEACH TOWER, Singapore 189767 | Shanghai United Intelligence MRI Image Analysis Software |
预览显示 10 行、12 列。完整数据请使用表格搜索或下载 CSV。
字段
| 字段 | 类型 | 分类字段 |
|---|---|---|
| Device Name | Text | 否 |
| Description | Text | 否 |
| Medical Speciality Area | Text | 是 |
| Medical Device Class | Text | 是 |
| Device Registration Number | Text | 否 |
| Registration Date | Text | 否 |
| Change Notification Approval Date | Text | 否 |
| Product Owner Name | Text | 否 |
| Product Owner Address | Text | 否 |
| Registrant Name | Text | 是 |
| Registrant Address | Text | 是 |
| Model Name | Text | 否 |
| Model Identifier | Text | 否 |