Ningbo Luke Medical Devices Co., Ltd.
Manufacturer and brand owner in Yuyao, Zhejiang, China. 27 device types, 1 product catalogued.
Ningbo Luke Medical Devices Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Stirrups, Mask, Oxygen and 25 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2017.
27device types registered with the FDA
1product
Registration
| Registered name | NINGBO LUKE MEDICAL DEVICES CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013909820 |
| FEI number | 3013909820 |
| DUNS | 541284393 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 宁波路加医疗器械有限公司 |
|---|---|
| Unified social credit code | 91330281573651986X |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Yuyao |
|---|---|
| Province | Zhejiang |
| Address | Gujiayan, Yangming Road, 315400 Yuyao City |
| Postal code | 315400 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Catheter | Class 1 | Drainage Tubes, Drainage Bag | 2020 | 33 |
| Accessory, Surgical Apparel | Class 1 | Face Shield | 2020 | 439 |
| Airway, Nasopharyngeal | Class 1 | Nasopharyngeal Airway | 2020 | 52 |
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Laryngeal Mask Airways, Oropharyngeal Airway | 2017 | 84 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class 1 | Wound Drainage Systems, PVC wound drainage system, PVC reservoirs | 2017 | 58 |
| Bag, Reservoir | Class 1 | Latex free breathing bag | 2023 | 28 |
| Brush, Cleaning, Tracheal Tube | Class 1 | Tracheal Tube | 2020 | 26 |
| Cannula, Nasal, Oxygen | Class 1 | Nasal Oxygen Cannulas | 2017 | 97 |
| Cannula, Surgical, General & Plastic Surgery | Class 1 | CPAP Tube, Disposable Breathing Circuits | 2020 | 14 |
| Catheter And Tip, Suction | Class 2 | Suction Tubing with Yankauer Handle | 2025 | 70 |
| Catheter, Irrigation | Class 1 | Silicone Reservoirs | 2017 | 24 |
| Cup, Menstrual | Class 2 | Canack Cup, First greener cup, Cuttie cup, Luna Cup, Vivi Cup, Luke Cup and 9 more | 2017 | 20 |
| Enteral Administration Kit (Adult & Pediatric) | Class 2 | stomach tube (Gastric Calibration Tube ) | 2019 | 7 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Disposable Face Mask | 2020 | 182 |
| Mask, Gas, Anesthetic | Class 1 | Anesthesia Mask | 2020 | 71 |
| Mask, Oxygen | Class 1 | Oxygen Masks, CPAP Mask, Aerosol | 2017 | 126 |
| Mask, Oxygen, Low Concentration, Venturi | Class 1 | Venturi Mask | 2020 | 46 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | Non-breathing Oxygen Mask | 2020 | 72 |
| Mask, Scavenging | Class 1 | Face Mask | 2020 | 158 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | Nebulize Mask | 2020 | 57 |
| Needle, Catheter | Class 1 | PVC/Silicone wound drainage tube | 2017 | 7 |
| Non-Surgical Gown | Class 1 | Isolation Gown | 2020 | 318 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Protective Goggles | 2020 | 384 |
| Snare, Surgical | Class 1 | Silicone Loops | 2020 | 9 |
| Stirrups | Class 1 | Heat and Moisture Exchangers | 2017 | 2 |
| Strap, Head, Gas Mask | Class 1 | Headgear | 2020 | 29 |
| Vibrator For Therapeutic Use, Genital | Class 2 | Kegel Ball | 2020 | 21 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Lucoolife | HHE | 3 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2011 |
|---|---|
| Main products | Laryngeal mask airway, Drainage tubes, Respiratory products, Anesthesia products |
| Certifications | CFDA, EU ISO13485, US FDA |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.